Application 022573

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	TABLET, CHEWABLE;ORAL	0.025MG;0.8MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	2010-12-22

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2010-12-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022573-001	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	0.025MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	2010-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022573-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022573-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022573-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022573-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022573-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022573-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022573-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022573-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022573-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022573-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022573-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022573-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022573-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022573-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022573-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022573-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022573-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022573-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022573-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022573-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022573-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022573-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022573-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022573-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022573-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022573-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022573-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022573-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022573-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022573-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022573-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022573-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022573-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022573-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022573-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022573-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022573-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022573-001	6667050	2019-04-06	U-828	Drug product	2011-01-20	`ea99ee380514…`

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
Norethindrone and ethinyl estradiol and ferrous fumarate	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE TABLET	Naari Pte Limited	1f7a19f1-fd30-4bd2-aab6-926d911d2579	2024-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Norethindrone and ethinyl estradiol and ferrous fumarate
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Mylan Pharmaceuticals Inc.	aabda044-9f17-4f1f-bb8d-2a78c9066fdc	2021-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6030	GENERESS Fe	norethindrone and ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0023-6030	GENERESS Fe	norethindrone and ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0023-6030	GENERESS Fe	norethindrone and ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
0023-6030	GENERESS Fe	norethindrone and ethinyl estradiol and ferrous fumarate	Allergan, Inc.	NDA	Current
52544-064	Layolis Fe	norethindrone, ethinyl estradiol, and ferrous fumarate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52544-064	Layolis Fe	norethindrone, ethinyl estradiol, and ferrous fumarate	Actavis Pharma, Inc.	NDA	Current
52544-064	Layolis Fe	norethindrone, ethinyl estradiol, and ferrous fumarate	Actavis Pharma, Inc.	NDA	Current
52544-064	Layolis Fe	norethindrone, ethinyl estradiol, and ferrous fumarate	Actavis Pharma, Inc.	NDA	Current
52544-204	GENERESS Fe	norethindrone and ethinyl estradiol and ferrous fumarate	Actavis Pharma, Inc.	NDA	Current
52544-204	GENERESS Fe	norethindrone and ethinyl estradiol and ferrous fumarate	Actavis Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74636	SUPPL	2023-06-27
74632	SUPPL	2023-06-27
70969	SUPPL	2022-05-04
70944	SUPPL	2022-05-03
49385	SUPPL	2017-08-15
49304	SUPPL	2017-08-09
44781	ORIG	2011-07-26
42561	ORIG	2011-07-26
29874	ORIG	2010-12-28
17727	ORIG	2010-12-26
63531	ORIG	1900-01-01
63530	ORIG	1900-01-01
63529	ORIG	1900-01-01