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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022573

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NDA 022573 describes NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Teva Branded Pharm, Xiromed, Amneal Pharms, Barr, Lupin Ltd, and Naari Pte, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for 022573

Tradename:	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Applicant:	Teva Branded Pharm
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Suppliers and Packaging for NDA: 022573

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	52544-064	52544-064-31	3 BLISTER PACK in 1 CARTON (52544-064-31) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	0.025MG;0.8MG
Approval Date:	Dec 22, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022573

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	5,552,394	⤷ Get Started Free
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	6,667,050	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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