FDA Orange Book · active-ingredient family
Cloxacillin sodium
Cloxacillin sodium is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TEGOPEN · NDA 050192
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEGOPEN | APOTHECON | NDA 050192 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOXACILLIN SODIUM | TEVA | ANDA 062978 | — | Apr 06, 1989 | |
| CLOXACILLIN SODIUM×2 | APOTHECON | ANDA 061452 | — | Approved Prior to Jan 1, 1982 | |
| CLOXACILLIN SODIUM×2 | TEVA | ANDA 062240 | — | Approved Prior to Jan 1, 1982 | |
| CLOXAPEN×2 | GLAXOSMITHKLINE | ANDA 061806 | — | Approved Prior to Jan 1, 1982 | |
| CLOXAPEN×2 | GLAXOSMITHKLINE | ANDA 062233 | — | Approved Prior to Jan 1, 1982 | |
| CLOXACILLIN SODIUM | TEVA | ANDA 062268 | — | Approved Prior to Jan 1, 1982 | |
| TEGOPEN | APOTHECON | ANDA 061453 | — | 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.
Cloxacillin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
