Orange Book product · Brand (NDA)
DEPO-SUBQ PROVERA 104
MEDROXYPROGESTERONE ACETATE
At a glance
Dec 17, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2004
21 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
MEDROXYPROGESTERONE ACETATE
Strength
104MG/0.65ML
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 021583
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1992DEPO-PROVERABrand (NDA)
NDA 020246 · PFIZER
- —DEPO-PROVERABrand (NDA)
NDA 012541 · PFIZER
- —PROVERABrand (NDA)
NDA 011839 · 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.

