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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 016029

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NDA 016029 describes OVULEN-21, which is a drug marketed by Gd Searle Llc and is included in one NDA. Additional details are available on the OVULEN-21 profile page.

The generic ingredient in OVULEN-21 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 016029

Tradename:	OVULEN-21
Applicant:	Gd Searle Llc
Ingredient:	ethynodiol diacetate; mestranol
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-20			Strength	1MG;0.1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	1MG;0.1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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