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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 070685

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NDA 070685 describes NORETHINDRONE AND ETHINYL ESTRADIOL, which is a drug marketed by Watson Labs, Watson Pharms Teva, Dr Reddys Labs Sa, Mylan Labs Ltd, Naari Pte, Watson Labs Teva, Xiromed, Teva Branded Pharm, Amneal Pharms, Barr, and Lupin Ltd, and is included in twenty-four NDAs. It is available from one supplier. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL 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 070685

Tradename:	NORETHINDRONE AND ETHINYL ESTRADIOL
Applicant:	Watson Pharms Teva
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.035MG;1MG
Approval Date:	Jan 29, 1987	TE:		RLD:	No

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