FDA Orange Book · active-ingredient family
Protamine sulfate
Protamine sulfate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROTAMINE SULFATE · NDA 006460
2
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROTAMINE SULFATERLD×2 | LILLY | NDA 006460 | — | Approved Prior to Jan 1, 1982 | |
| PROTAMINE SULFATE×2 | PHARMACIA AND UPJOHN | NDA 007413 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROTAMINE SULFATE×2 | HIKMA | ANDA 089475 | — | Jun 07, 1988 | |
| PROTAMINE SULFATE×2 | FRESENIUS KABI USA | ANDA 089454 | — | Apr 07, 1987 | |
| PROTAMINE SULFATE | HIKMA | ANDA 089474 | — | Nov 05, 1986 |
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.
Protamine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
