Orange Book product · Brand (NDA)
MEGACE
MEGESTROL ACETATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MEGESTROL ACETATE
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 016979
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2005MEGACE ESBrand (NDA)
NDA 021778 · ENDO OPERATIONS
- 1993MEGACEBrand (NDA)
NDA 020264 · BRISTOL MYERS SQUIBB
- 2017MEGESTROL ACETATEGeneric (ANDA)
ANDA 204688 · CHARTWELL
- 2017MEGESTROL ACETATEGeneric (ANDA)
ANDA 203960 · HIKMA
- 2014MEGESTROL ACETATEGeneric (ANDA)
ANDA 203139 · TWI PHARMS
- 2006MEGESTROL ACETATEGeneric (ANDA)
ANDA 077404 · NOVITIUM PHARMA
- 2004MEGESTROL ACETATEGeneric (ANDA)
ANDA 076721 · PHARMOBEDIENT
- 2003MEGESTROL ACETATEGeneric (ANDA)
ANDA 075681 · TEVA PHARMS
- 2002MEGESTROL ACETATEGeneric (ANDA)
ANDA 075997 · HIKMA
- 2001MEGESTROL ACETATEGeneric (ANDA)
ANDA 075671 · STRIDES PHARMA INTL
- 1998MEGESTROL ACETATEGeneric (ANDA)
ANDA 074745 · TEVA
- 1996MEGESTROL ACETATEGeneric (ANDA)
ANDA 074621 · BARR
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.
