Orange Book product · Brand (NDA)
MEGACE
MEGESTROL ACETATE
At a glance
Sep 10, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 1993
33 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
MEGESTROL ACETATE
Strength
40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 020264
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
- —MEGACEBrand (NDA)
NDA 016979 · 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.
