Application 021490

Type: NDA
Sponsor: APIL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEMCON FE	ETHINYL ESTRADIOL; NORETHINDRONE	TABLET, CHEWABLE;ORAL	0.035MG;0.4MG	Yes	No

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
N021490-001	FEMCON FE	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-11-14

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	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021490-001	FEMCON FE	0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021490-001	FEMCON FE	0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021490-001	FEMCON FE	0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-11-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021490-001	FEMCON FE	0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-11-14	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021490-001	6667050	2019-04-06	U-1	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021490-001	6667050	2019-04-06	U-1	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021490-001	6667050	2019-04-06	U-1	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021490-001	6667050	2019-04-06	U-1	Drug product	`ea99ee380514…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-5970	FEMCON Fe	norethindrone and ethinyl estradiol, and ferrous fumarate	Allergan, Inc.	NDA	Current
68180-897	Norethindrone and Ethinyl Estradiol and Ferrous Fumarate	Norethindrone and Ethinyl Estradiol	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-898	WYMZYA FE	norethindrone and ethinyl estradiol, and ferrous fumarate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68180-899	WYMZYA FE	norethindrone and ethinyl estradiol, and ferrous fumarate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49377	SUPPL	2017-08-15
49300	SUPPL	2017-08-09
45528	SUPPL	2016-10-12
45416	SUPPL	2016-09-29
15593	SUPPL	2008-01-18
5533	SUPPL	2008-01-15
5532	SUPPL	2007-02-12
15592	SUPPL	2007-02-02
21690	ORIG	2005-02-02
5531	ORIG	2003-11-28
37062	ORIG	2003-11-14