Sharp Corporation blanket no changes certification of product listing

Manufacturer: Sharp Corporation
Effective date: 2017-10-12
Label type: BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:48:37

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68968-0514-1	EA - Each	68968-0514	46d2ef5d-c110-4cb8-a5c9-2a1a640e8b0d	1	2015-11-12
68968-0514-8	EA - Each	68968-0514	93402b80-3a7d-41b0-a900-4f70e0911835	1	2014-10-03
68968-5552-3	EA - Each	68968-5552	6b3d1450-f2d6-4f58-8156-d57b5aca7405	1	2012-07-24
68968-5553-3	EA - Each	68968-5553	6d9a830b-a3f5-4e8c-9f5d-6e1dbc30ad76	1	2012-07-24
68968-5554-3	EA - Each	68968-5554	7a64d1bd-8312-4ed3-bbef-5332ebaaee74	1	2012-07-24
68968-5555-3	EA - Each	68968-5555	65e05faf-d938-4fe6-a732-5db7ff7d97c4	1	2012-07-24
68968-6610-1	EA - Each	68968-6610	1a4b8286-eed1-42e4-b48f-c18a8e036658	1	2015-11-12
68968-6610-8	EA - Each	68968-6610	5d671151-26f2-45e2-809b-9de65e62b304	1	2013-02-13
68968-6625-1	EA - Each	68968-6625	6cdb32c6-6e80-4545-81a0-01dac6f663e2	1	2016-09-02
68968-6625-8	EA - Each	68968-6625	3234568d-6189-4025-bcf9-79c1494b0cb4	1	2015-01-05
68968-6637-1	EA - Each	68968-6637	7720af54-e999-4121-9e44-39d784d83dd2	1	2015-11-12
68968-6637-8	EA - Each	68968-6637	f2091cb8-c18d-4cad-a1d7-559d8db330bd	1	2013-02-13
68968-6650-1	EA - Each	68968-6650	6398c0d2-2adb-4412-9833-9595ed039490	1	2015-11-12
68968-6650-8	EA - Each	68968-6650	c73ac728-0040-4c77-bb91-622def268228	1	2013-02-13
68968-6675-1	EA - Each	68968-6675	2f922438-7867-4be6-bde5-beaf6c79f9a8	1	2015-11-12
68968-6675-8	EA - Each	68968-6675	e9ac996e-abe5-4a34-aaf4-be49dcc97289	1	2013-02-13

NDC Codes#

Product NDC table
Product NDC
68968-0514
68968-5552
68968-5553
68968-5554
68968-5555
68968-6610
68968-6625
68968-6637
68968-6650
68968-6675

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 3 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020870-001	COMBIPATCH	ESTRADIOL; NORETHINDRONE ACETATE	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	1998-08-07
N020870-002	COMBIPATCH	ESTRADIOL; NORETHINDRONE ACETATE	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	1998-08-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`74a2ff9319b5…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021514-001	DAYTRANA	METHYLPHENIDATE	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06
N021514-002	DAYTRANA	METHYLPHENIDATE	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06
N021514-003	DAYTRANA	METHYLPHENIDATE	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06
N021514-004	DAYTRANA	METHYLPHENIDATE	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021514-001	AB
N021514-002	AB
N021514-003	AB
N021514-004	AB

Observed Orange Book product history#

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021514-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021514-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021514-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021514-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021514-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021514-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021514-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021514-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021514-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021514-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021514-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021514-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 468 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-002	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-003	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	8632802	2025-10-07		Drug product	2014-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	9034370	2025-10-07		Drug product	2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021514-004	9668981	2025-10-07	U-2024		2017-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-002	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-003	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	8632802	2025-10-07		Drug product	2014-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	9034370	2025-10-07		Drug product	2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021514-004	9668981	2025-10-07	U-2024		2017-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-002	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-003	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	8632802	2025-10-07		Drug product	2014-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	9034370	2025-10-07		Drug product	2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021514-004	9668981	2025-10-07	U-2024		2017-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	8632802	2025-10-07		Drug product	2014-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	9034370	2025-10-07		Drug product	2015-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-001	9668981	2025-10-07	U-2024		2017-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021514-002	8632802	2025-10-07		Drug product	2014-02-04	`b8a1b40f171c…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203752-001	MINIVELLE	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29
N203752-002	MINIVELLE	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29
N203752-003	MINIVELLE	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29
N203752-004	MINIVELLE	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29
N203752-005	MINIVELLE	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N203752-001	AB3
N203752-002	AB3
N203752-003	AB3
N203752-004	AB3
N203752-005	AB3

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203752-001	9730900	2028-07-10	U-2086		2017-08-18
N203752-001	9833419	2028-07-10		Drug product	2017-12-14
N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22
N203752-002	9730900	2028-07-10	U-2086		2017-08-18
N203752-002	9833419	2028-07-10		Drug product	2017-12-14
N203752-002	8231906	2030-07-04		Drug substance, Drug product
N203752-003	9730900	2028-07-10	U-2086		2017-08-18
N203752-003	9833419	2028-07-10		Drug product	2017-12-14
N203752-003	8231906	2030-07-04		Drug substance, Drug product
N203752-004	9730900	2028-07-10	U-2086		2017-08-18
N203752-004	9833419	2028-07-10		Drug product	2017-12-14
N203752-004	8231906	2030-07-04		Drug substance, Drug product
N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18
N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18
N203752-005	9833419	2028-07-10		Drug product	2017-12-14
N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08

Observed Orange Book product history#

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N203752-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-002	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-003	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-004	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-005	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203752-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203752-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203752-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203752-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203752-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203752-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203752-005	AB3	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 718 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-003	8231906	2030-07-04		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-004	9730900	2028-07-10	U-2086		2017-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-004	9833419	2028-07-10		Drug product	2017-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-004	8231906	2030-07-04		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-005	9833419	2028-07-10		Drug product	2017-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-003	8231906	2030-07-04		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	9730900	2028-07-10	U-2086		2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-004	8231906	2030-07-04		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	9833419	2028-07-10		Drug product	2017-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minivelle	ESTRADIOL	Noven Therapeutics, LLC	6c5c47ab-28ee-11e1-bfc2-0800200c9a66	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 68968-6637 ndc (product): 68968-6675 ndc (product): 68968-6610 ndc (product): 68968-6625 ndc (product): 68968-6650
Daytrana	METHYLPHENIDATE	Noven Therapeutics, LLC	2c312c31-3198-4775-91ab-294e0b4b9e7f	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 68968-5552 ndc (product): 68968-5553 ndc (product): 68968-5554 ndc (product): 68968-5555
CombiPatch (estradiol/norethindrone acetate transdermal system)	ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM	Noven Therapeutics, LLC	83198ef1-11c4-11e4-9191-0800200c9a66	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 68968-0514

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.