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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 017576

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NDA 017576 describes OVCON-50, which is a drug marketed by Warner Chilcott and Warner Chilcott Llc and is included in two NDAs. Additional details are available on the OVCON-50 profile page.

The generic ingredient in OVCON-50 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 017576

Tradename:	OVCON-50
Applicant:	Warner Chilcott Llc
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	0.05MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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