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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078965

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NDA 078965 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 078965

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.035MG;0.4MG
Approval Date:	Aug 5, 2010	TE:	AB	RLD:	No

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