Application 021514

Type: NDA
Sponsor: NOVEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAYTRANA	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	10MG/9HR (1.1MG/HR)	Yes	No
002	DAYTRANA	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	15MG/9HR (1.6MG/HR)	Yes	No
003	DAYTRANA	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	20MG/9HR (2.2MG/HR)	Yes	No
004	DAYTRANA	METHYLPHENIDATE	FILM, EXTENDED RELEASE;TRANSDERMAL	30MG/9HR (3.3MG/HR)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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#

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 5 · 168 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
2026-08-18 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-001	DAYTRANA	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-002	DAYTRANA	15MG/9HR (1.6MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-003	DAYTRANA	20MG/9HR (2.2MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2006-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-004	DAYTRANA	30MG/9HR (3.3MG/HR)	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2006-04-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021514-004	AB	1	`d8e5a09893c0…`

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…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Transdermal System	METHYLPHENIDATE	PADAGIS US LLC	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021514 application number: NDA021514
Daytrana	METHYLPHENIDATE	Noven Therapeutics, LLC	2c312c31-3198-4775-91ab-294e0b4b9e7f	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021514 application number: NDA021514 ndc (product): 68968-5552 ndc (product): 68968-5553 ndc (product): 68968-5554 ndc (product): 68968-5555

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5552	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5553	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5554	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current
68968-5555	Daytrana	methylphenidate	Noven Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83511	SUPPL	2025-09-25
83510	SUPPL	2025-09-25
83440	SUPPL	2025-09-25
80474	SUPPL	2024-12-03
80466	SUPPL	2024-12-02
75791	SUPPL	2023-10-17
75758	SUPPL	2023-10-16
72063	SUPPL	2022-09-12
67967	SUPPL	2021-06-29
67966	SUPPL	2021-06-29
67942	SUPPL	2021-06-29
60692	SUPPL	2019-10-28
60634	SUPPL	2019-10-23
56336	SUPPL	2018-11-08
52739	SUPPL	2018-02-27
50409	SUPPL	2017-11-14
50354	SUPPL	2017-11-09
46777	SUPPL	2017-01-10
46717	SUPPL	2017-01-06
45106	SUPPL	2016-08-23
45151	SUPPL	2016-08-19
27992	SUPPL	2015-08-18
37118	SUPPL	2015-08-17
15649	SUPPL	2015-04-21
27991	SUPPL	2015-04-20
15648	SUPPL	2013-12-17
27990	SUPPL	2013-12-16
37117	SUPPL	2013-06-07
27989	SUPPL	2013-06-07
27988	SUPPL	2010-10-20
37116	SUPPL	2010-10-18
15647	SUPPL	2010-07-06
27987	SUPPL	2010-07-02
5594	SUPPL	2010-07-02
27986	SUPPL	2009-12-24
37115	SUPPL	2009-12-16
21708	ORIG	2008-11-14
37114	SUPPL	2008-02-14
37112	SUPPL	2008-02-14
15646	SUPPL	2008-02-14
44132	ORIG	2007-05-18
37113	SUPPL	2007-05-07
5593	SUPPL	2007-05-07
15645	SUPPL	2006-08-04
5592	SUPPL	2006-08-04
27985	ORIG	2006-04-13
54055	ORIG	1900-01-01
53334	ORIG	1900-01-01
53333	ORIG	1900-01-01
53332	ORIG	1900-01-01