FDA Orange Book · active-ingredient family
Cephalothin sodium
Cephalothin sodium is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KEFLIN · NDA 050482
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KEFLIN×4 | LILLY | NDA 050482 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEPHALOTHIN SODIUM×2 | ABRAXIS PHARM | ANDA 062666 | — | Jun 10, 1987 | |
| CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER×2 | BAXTER HLTHCARE | ANDA 062730 | — | Mar 05, 1987 | |
| CEPHALOTHIN SODIUM×2 | ABBOTT | ANDA 062547 | — | Sep 11, 1985 | |
| CEPHALOTHIN SODIUM×2 | ABBOTT | ANDA 062548 | — | Sep 11, 1985 | |
| KEFLIN IN PLASTIC CONTAINER×2 | LILLY | ANDA 062549 | — | Sep 10, 1985 | |
| CEPHALOTHIN×4 | INTL MEDICATION | ANDA 062426 | — | May 03, 1985 | |
| CEPHALOTHIN SODIUM×3 | BRISTOL | ANDA 062464 | — | May 07, 1984 | |
| CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER×6 | BAXTER HLTHCARE | ANDA 062422 | — | Jan 31, 1984 | |
| SEFFIN×3 | GLAXOSMITHKLINE | ANDA 062435 | — | Nov 15, 1983 |
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.
Cephalothin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
