FDA Orange Book · active-ingredient family
Carboprost tromethamine
Carboprost tromethamine is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HEMABATE · NDA 017989
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HEMABATERLD | PFIZER | NDA 017989 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARBOPROST TROMETHAMINE | SOMERSET THERAPS LLC | ANDA 219529 | AP | May 27, 2026 | |
| CARBOPROST TROMETHAMINE | MICRO LABS | ANDA 218013 | AP | Apr 03, 2024 | |
| CARBOPROST TROMETHAMINE | ANI PHARMS | ANDA 215901 | — | Jan 25, 2024 | |
| CARBOPROST TROMETHAMINE | GLAND | ANDA 217657 | AP | Aug 07, 2023 | |
| CARBOPROST TROMETHAMINE | ONESOURCE SPECIALTY | ANDA 216897 | AP | Jul 25, 2023 | |
| CARBOPROST TROMETHAMINE | ALEMBIC | ANDA 217198 | AP | Jun 15, 2023 | |
| CARBOPROST TROMETHAMINE | EUGIA PHARMA | ANDA 216939 | AP | May 25, 2023 | |
| CARBOPROST TROMETHAMINE | SOLA PHARMS | ANDA 216824 | AP | May 19, 2023 | |
| CARBOPROST TROMETHAMINE | CAPLIN | ANDA 216882 | AP | Feb 13, 2023 | |
| CARBOPROST TROMETHAMINE | LONG GROVE PHARMS | ANDA 214499 | AP | Aug 09, 2022 | |
| CARBOPROST TROMETHAMINE | AMNEAL | ANDA 215337 | AP | Jan 27, 2022 | |
| CARBOPROST TROMETHAMINE | SUNNY | ANDA 213118 | AP | Mar 25, 2021 | |
| CARBOPROST TROMETHAMINE | DR REDDYS | ANDA 211941 | AP | Jul 02, 2019 |
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.
Carboprost tromethamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
