FDA Orange Book · active-ingredient family
Hydroxyprogesterone caproate
Hydroxyprogesterone caproate is approved as 4 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DELALUTIN · NDA 010347
4
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DELALUTINRLD×2 | BRISTOL MYERS SQUIBB | NDA 010347 | — | Approved Prior to Jan 1, 1982 | |
| DELALUTINRLD×2 | BRISTOL MYERS SQUIBB | NDA 016911 | — | Approved Prior to Jan 1, 1982 | |
| HYDROXYPROGESTERONE CAPROATE×2 | ALLERGAN | NDA 017439 | — | Approved Prior to Jan 1, 1982 | |
| HYDROXYPROGESTERONE CAPROATE | EPIC PHARMA LLC | NDA 018004 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROXYPROGESTERONE CAPROATE | EUGIA PHARMA | ANDA 211142 | — | May 09, 2019 | |
| HYDROXYPROGESTERONE CAPROATE | ASPEN GLOBAL INC | ANDA 200271 | — | Aug 24, 2015 |
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.
Hydroxyprogesterone caproate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
