Orange Book product · Brand (NDA)
PROVERA
MEDROXYPROGESTERONE ACETATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MEDROXYPROGESTERONE ACETATE
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 011839
Product number
001
Marketing status
RX
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.
- 2004DEPO-SUBQ PROVERA 104Brand (NDA)
NDA 021583 · PFIZER
- 1992DEPO-PROVERABrand (NDA)
NDA 020246 · PFIZER
- —DEPO-PROVERABrand (NDA)
NDA 012541 · PFIZER
- 2023MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 215397 · AMNEAL
- 2023MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 214309 · HIKMA
- 2022MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 212844 · EUGIA PHARMA
- 2022MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 212824 · EUGIA PHARMA
- 2019MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 210760 · SUN PHARM
- 2019MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 210761 · SUN PHARM
- 2019MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 210335 · CIPLA
- 2018MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 210227 · XIROMED
- 2017MEDROXYPROGESTERONE ACETATEGeneric (ANDA)
ANDA 077235 · AMPHASTAR PHARMS INC
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.
