Is there a generic for Estradiol; norgestimate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Estradiol; norgestimate, referencing the brand PREFEST. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Estradiol; norgestimate?

PREFEST (NDA 021040, TEVA WOMENS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Estradiol; norgestimate are approved?

Estradiol; norgestimate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Estradiol; norgestimate

Estradiol; norgestimate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PREFEST · NDA 021040

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PREFESTRLD	TEVA WOMENS	NDA 021040	—	Oct 22, 1999

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ESTRADIOL AND NORGESTIMATE	BARR	ANDA 076812	—	Apr 29, 2005

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.

Estradiol; norgestimate — frequently asked questions

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

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