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FDA Orange Book · active-ingredient family

Megestrol acetate

Megestrol acetate is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MEGACE ES · NDA 021778

3

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension, tablet

ProductApplicantApplicationTEApproved
MEGACE ESRLDENDO OPERATIONSNDA 021778—Jul 05, 2005
MEGACERLDBRISTOL MYERS SQUIBBNDA 020264—Sep 10, 1993
MEGACERLD×2BRISTOL MYERS SQUIBBNDA 016979—Approved Prior to Jan 1, 1982

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
MEGESTROL ACETATECHARTWELLANDA 204688—Dec 01, 2017
MEGESTROL ACETATEHIKMAANDA 203960—Jun 09, 2017
MEGESTROL ACETATETWI PHARMSANDA 203139—Aug 27, 2014
MEGESTROL ACETATENOVITIUM PHARMAANDA 077404ABFeb 16, 2006
MEGESTROL ACETATEPHARMOBEDIENTANDA 076721ABNov 01, 2004
MEGESTROL ACETATETEVA PHARMSANDA 075681—May 05, 2003
MEGESTROL ACETATEHIKMAANDA 075997—Feb 15, 2002
MEGESTROL ACETATESTRIDES PHARMA INTLANDA 075671ABJul 25, 2001
MEGESTROL ACETATETEVAANDA 074745—Feb 27, 1998
MEGESTROL ACETATE×2BARRANDA 074621ABAug 16, 1996
MEGESTROL ACETATE×2HIKMAANDA 074458—Sep 29, 1995
MEGESTROL ACETATESTRIDES PHARMA INTLANDA 072422ABAug 08, 1988
MEGESTROL ACETATESTRIDES PHARMA INTLANDA 072423ABAug 08, 1988
MEGESTROL ACETATEUSL PHARMAANDA 070646—Oct 02, 1987
MEGESTROL ACETATEUSL PHARMAANDA 070647—Oct 02, 1987

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.

Megestrol acetate — frequently asked questions

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

Agent CTA Background

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