Is there a generic for Dienestrol?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Dienestrol, referencing the brand DIENESTROL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dienestrol?

DIENESTROL (NDA 006110, ORTHO MCNEIL PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dienestrol are approved?

Dienestrol is approved in the following dosage forms: cream, suppository.

FDA Orange Book · active-ingredient family

Dienestrol

Dienestrol is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIENESTROL · NDA 006110

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, suppository

Product	Applicant	Application	TE	Approved
DIENESTROL	ORTHO MCNEIL PHARM	NDA 006110	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
DV	SANOFI AVENTIS US	ANDA 083518	—	Approved Prior to Jan 1, 1982
ESTRAGUARD	SOLVAY	ANDA 084436	—	Approved Prior to Jan 1, 1982
DV	SANOFI AVENTIS US	ANDA 083517	—	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.

Dienestrol — frequently asked questions

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

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