Application 213950

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	FILM, EXTENDED RELEASE;TRANSDERMAL	0.035MG/24HR;0.15MG/24HR	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2021-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213950-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	BX	2021-02-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213950-001	ETHINYL ESTRADIOL AND NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-02-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213950-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213950-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213950-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213950-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213950-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213950-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213950-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213950-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213950-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213950-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213950-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213950-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213950-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213950-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213950-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213950-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213950-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213950-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213950-001	BX	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213950-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213950-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213950-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213950-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213950-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213950-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213950-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213950-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213950-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213950-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213950-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213950-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213950-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213950-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213950-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213950-001	BX	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213950-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213950-001	CGT	2021-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213950-001	CGT	2021-08-25	`87673890dc5c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	AvKARE	fbbd12dd-c538-2869-e053-6294a90a1a38	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	Bryant Ranch Prepack	77230a20-4269-4abf-ae2a-ac5ccafef565	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950
ZAFEMY	NORELGESTROMIN AND ETHINYL ESTRADIOL	Amneal Pharmaceuticals LLC	5ee34c07-65af-42b8-a98f-e299ff90a8a1	2022-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950 ndc (product): 65162-358
Norelgestromin and Ethinly Estradiol	NORELGESTROMIN AND ETHINLY ESTRADIOL	Amneal Pharmaceuticals NY LLC	36445b6a-e0f2-42f7-a8f3-5b80c90b87dd	2022-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213950 application number: ANDA213950 ndc (product): 69238-1521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-358	ZAFEMY	Norelgestromin and Ethinly Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-358	ZAFEMY	Norelgestromin and Ethinly Estradiol	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1521	Norelgestromin and Ethinly Estradiol	Norelgestromin and Ethinly Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1521	Norelgestromin and Ethinly Estradiol	Norelgestromin and Ethinly Estradiol	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79316	ORIG	2024-08-06