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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 071044

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NDA 071044 describes NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), which is a drug marketed by Watson Labs and Watson Labs Teva and is included in two NDAs. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) profile page.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) 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 071044

Tradename:	NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
Applicant:	Watson Labs Teva
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.035MG,0.035MG;0.5MG,1MG
Approval Date:	Apr 1, 1988	TE:		RLD:	No

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