NDA 50637, held by Pharmacia And Upjohn. Cefmetazole Sodium.
As of Nov 13, 2026, NDA 50637 (Zefazone), held by Pharmacia And Upjohn, was first approved by FDA on Dec 11, 1989, with 7 approved supplements and 0 published complete response letters.
| Sep 17, 2001 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Sep 17, 2001 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Sep 29, 1992 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Dec 11, 1989 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| ZefazoneEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefmetazole Sodium | DiscontinuedReference drug |
| ZefazoneEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefmetazole Sodium | DiscontinuedReference drug |
| Sep 17, 2001 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Sep 17, 2001 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Sep 17, 2001 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 8, 1993 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1993 | Supplement 4Labeling | Approved | None posted |
| Jul 30, 1993 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 29, 1992 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Dec 11, 1989 | Original applicationNew molecular entity · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
