FDA Orange Book · active-ingredient family
Medroxyprogesterone acetate
Medroxyprogesterone acetate is approved as 4 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEPO-SUBQ PROVERA 104 · NDA 021583
4
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEPO-SUBQ PROVERA 104RLD | PFIZER | NDA 021583 | — | Dec 17, 2004 | |
| DEPO-PROVERARLD | PFIZER | NDA 020246 | AB | Oct 29, 1992 | |
| DEPO-PROVERARLD×2 | PFIZER | NDA 012541 | — | Approved Prior to Jan 1, 1982 | |
| PROVERARLD×3 | PFIZER | NDA 011839 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEDROXYPROGESTERONE ACETATE | AMNEAL | ANDA 215397 | AB | Jun 07, 2023 | |
| MEDROXYPROGESTERONE ACETATE | HIKMA | ANDA 214309 | — | Jan 05, 2023 | |
| MEDROXYPROGESTERONE ACETATE | EUGIA PHARMA | ANDA 212844 | AB | Aug 31, 2022 | |
| MEDROXYPROGESTERONE ACETATE | EUGIA PHARMA | ANDA 212824 | AB | Aug 22, 2022 | |
| MEDROXYPROGESTERONE ACETATE | SUN PHARM | ANDA 210760 | — | May 01, 2019 | |
| MEDROXYPROGESTERONE ACETATE | SUN PHARM | ANDA 210761 | — | Apr 24, 2019 | |
| MEDROXYPROGESTERONE ACETATE | CIPLA | ANDA 210335 | — | Jan 25, 2019 | |
| MEDROXYPROGESTERONE ACETATE | XIROMED | ANDA 210227 | AB | Oct 12, 2018 | |
| MEDROXYPROGESTERONE ACETATE | AMPHASTAR PHARMS INC | ANDA 077235 | AB | Nov 28, 2017 | |
| MEDROXYPROGESTERONE ACETATE | AMPHASTAR PHARMS INC | ANDA 077334 | AB | Nov 28, 2017 | |
| MEDROXYPROGESTERONE ACETATE | SANDOZ | ANDA 078711 | — | May 20, 2009 | |
| MEDROXYPROGESTERONE ACETATE | TEVA PHARMS USA | ANDA 076552 | — | Oct 27, 2004 | |
| MEDROXYPROGESTERONE ACETATE | HONG KONG | ANDA 076553 | AB | Jul 28, 2004 | |
| MEDROXYPROGESTERONE ACETATE×3 | DURAMED PHARMS BARR | ANDA 040311 | — | Dec 01, 1999 | |
| MEDROXYPROGESTERONE ACETATE×3 | BARR | ANDA 040159 | AB | Aug 09, 1996 | |
| CYCRIN | ESI | ANDA 081239 | — | Oct 30, 1992 | |
| CYCRIN | ESI | ANDA 081240 | — | Oct 30, 1992 | |
| CYCRIN | ESI | ANDA 089386 | — | Sep 09, 1987 | |
| MEDROXYPROGESTERONE ACETATE | UPSHER SMITH LABS | ANDA 088484 | — | Jul 26, 1984 | |
| AMEN | AMARIN PHARMS | ANDA 083242 | — | Approved Prior to Jan 1, 1982 | |
| CURRETAB | SOLVAY | ANDA 085686 | — | Approved Prior to Jan 1, 1982 |
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.
Medroxyprogesterone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
