Application 214292

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE	NORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE	CAPSULE;ORAL	0.02MG;1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE / ORAL			2021-07-20

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
2026-02-19 14:30 UTC	2026-02	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL	AB	2021-07-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214292-001	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.02MG;1MG	CAPSULE / ORAL		2021-07-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214292-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214292-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214292-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214292-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214292-001	AB	1	`782e0a99824c…`
2024-02-18 07:12 UTC	2024-02	A214292-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214292-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214292-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214292-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214292-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214292-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214292-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214292-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214292-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214292-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214292-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214292-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE	Amneal Pharmaceuticals LLC	e145ebc7-b6c0-474b-a712-c6f3b2342998	2023-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214292 application number: ANDA214292 ndc (product): 69238-1686

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-558	TAYSOFY	Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-558	TAYSOFY	Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1686	Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate	Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67814	ORIG	2021-06-15