Is there a generic for Estradiol; levonorgestrel?

The FDA Orange Book does not currently list an approved generic (ANDA) for Estradiol; levonorgestrel. It is available as 1 brand (NDA) application.

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

CLIMARA PRO (NDA 021258, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Estradiol; levonorgestrel are approved?

Estradiol; levonorgestrel is approved in the following dosage form: film, extended release.

FDA Orange Book · active-ingredient family

Estradiol; levonorgestrel

Estradiol; levonorgestrel is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CLIMARA PRO · NDA 021258

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · film, extended release

Product	Applicant	Application	TE	Approved
CLIMARA PRORLD	BAYER HLTHCARE	NDA 021258	—	Nov 21, 2003

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; levonorgestrel — frequently asked questions

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

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