FDA Orange Book · active-ingredient family
Bretylium tosylate
Bretylium tosylate is approved as 7 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BRETYLIUM TOSYLATE · NDA 019030
7
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRETYLIUM TOSYLATERLD | HOSPIRA | NDA 019030 | — | Apr 29, 1986 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER×2 | BAXTER HLTHCARE | NDA 019837 | — | Apr 12, 1989 | |
| BRETYLIUM TOSYLATE | HOSPIRA | NDA 019033 | — | Apr 29, 1986 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5%×3 | ABBOTT | NDA 019005 | — | Apr 29, 1986 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER×3 | B BRAUN | NDA 019121 | — | Apr 29, 1986 | |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER×3 | HOSPIRA INC | NDA 019008 | — | Apr 29, 1986 | |
| BRETYLOL | HOSPIRA | NDA 017954 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRETYLIUM TOSYLATE | BRECKENRIDGE | ANDA 204386 | — | Dec 21, 2018 | |
| BRETYLIUM TOSYLATE | LUITPOLD | ANDA 070891 | — | Jul 26, 1988 | |
| BRETYLIUM TOSYLATE | ASTRAZENECA | ANDA 071151 | — | Aug 10, 1987 | |
| BRETYLIUM TOSYLATE | ASTRAZENECA | ANDA 071152 | — | Aug 10, 1987 | |
| BRETYLIUM TOSYLATE | ASTRAZENECA | ANDA 071153 | — | Aug 10, 1987 | |
| BRETYLIUM TOSYLATE | ABRAXIS PHARM | ANDA 071298 | — | Feb 13, 1987 | |
| BRETYLIUM TOSYLATE | HIKMA | ANDA 070545 | — | May 14, 1986 | |
| BRETYLIUM TOSYLATE | HIKMA | ANDA 070546 | — | May 14, 1986 | |
| BRETYLIUM TOSYLATE | ABRAXIS PHARM | ANDA 070134 | — | Apr 29, 1986 | |
| BRETYLIUM TOSYLATE | INTL MEDICATION | ANDA 070119 | — | Apr 29, 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.
Bretylium tosylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
