Is there a generic for Ethynodiol diacetate; mestranol?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ethynodiol diacetate; mestranol. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Ethynodiol diacetate; mestranol?

OVULEN (NDA 016029, GD SEARLE LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethynodiol diacetate; mestranol are approved?

Ethynodiol diacetate; mestranol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ethynodiol diacetate; mestranol

Ethynodiol diacetate; mestranol is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OVULEN · NDA 016029

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
OVULEN×2	GD SEARLE LLC	NDA 016029	—	Approved Prior to Jan 1, 1982
OVULEN-28	GD SEARLE LLC	NDA 016705	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ethynodiol diacetate; mestranol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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