Application 203752

Type: NDA
Sponsor: NOVEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	Yes	No
002	MINIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	Yes	No
003	MINIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	Yes	No
004	MINIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	Yes	Yes
005	MINIVELLE	ESTRADIOL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	Yes	No

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

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#

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 6 · 210 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-001	MINIVELLE	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-002	MINIVELLE	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-003	MINIVELLE	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-004	MINIVELLE	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD, RS	2012-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-005	MINIVELLE	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	RLD	2014-09-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203752-005	AB3	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 702 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2026-02-19 14:30 UTC	2026-02	N203752-003	8231906	2030-07-04		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	9730900	2028-07-10	U-2086		2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-004	8231906	2030-07-04		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	9724310	2028-07-10		Drug substance, Drug product	2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	9730900	2028-07-10	U-2086	Drug product	2017-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	9833419	2028-07-10		Drug product	2017-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203752-005	8231906	2030-07-04		Drug substance, Drug product	2015-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	9730900	2028-07-10	U-2086		2017-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	9833419	2028-07-10		Drug product	2017-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-001	8231906	2030-07-04		Drug substance, Drug product	2013-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	9730900	2028-07-10	U-2086		2017-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	9833419	2028-07-10		Drug product	2017-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-002	8231906	2030-07-04		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	9730900	2028-07-10	U-2086		2017-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203752-003	9833419	2028-07-10		Drug product	2017-12-14	`31067a03dcf5…`

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 application applno (NDA): 203752 application number: NDA203752 ndc (product): 68968-6637 ndc (product): 68968-6675 ndc (product): 68968-6610 ndc (product): 68968-6625 ndc (product): 68968-6650
Estradiol	ESTRADIOL	A-S Medication Solutions	13f9c41b-417c-45e4-9a59-baf774fca78d	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203752 application number: NDA203752
Estradiol	ESTRADIOL	Noven Therapeutics, LLC	bf185599-2138-4083-9c52-2b95dce09ae0	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203752 application number: NDA203752 ndc (product): 68968-3475 ndc (product): 68968-3425 ndc (product): 68968-3437 ndc (product): 68968-3450 ndc (product): 68968-3410

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68968-3410	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3410	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3410	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3410	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3425	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3425	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3425	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3425	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3437	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3437	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3437	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3437	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3450	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3450	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3450	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3450	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3475	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3475	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3475	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-3475	Estradiol	estradiol	Noven Therapeutics, LLC	NDA AUTHORIZED GENERIC	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6610	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6625	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6637	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6650	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current
68968-6675	Minivelle	estradiol	Noven Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77573	SUPPL	2024-02-20
77548	SUPPL	2024-02-16
69955	SUPPL	2022-01-24
69044	SUPPL	2021-10-21
69043	SUPPL	2021-10-21
69034	SUPPL	2021-10-20
69033	SUPPL	2021-10-20
68972	SUPPL	2021-10-13
50279	SUPPL	2017-11-02
40324	SUPPL	2014-09-26
10247	SUPPL	2014-09-25
24447	ORIG	2013-03-28
22934	ORIG	2013-03-28
10246	ORIG	2012-11-01
19491	ORIG	2012-10-29