Details for New Drug Application (NDA): 016705

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NDA 016705 describes OVULEN-28, which is a drug marketed by Gd Searle Llc and is included in one NDA. Additional details are available on the OVULEN-28 profile page.

The generic ingredient in OVULEN-28 is ethynodiol diacetate; mestranol. There are four drug master file entries for this compound. Additional details are available on the ethynodiol diacetate; mestranol profile page.

Summary for 016705

Tradename:	OVULEN-28
Applicant:	Gd Searle Llc
Ingredient:	ethynodiol diacetate; mestranol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-28			Strength	1MG;0.1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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