NDA 50694, held by Pai Holdings Pharm. Cefotetan Disodium.
As of Nov 13, 2026, NDA 50694 (Cefotan In Plastic Container), held by Pai Holdings Pharm, was first approved by FDA on Jul 30, 1993, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 1993 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefotan In Plastic ContainerEQ 40MG BASE/ML · injectable;injection | Cefotetan Disodium | Discontinued |
| Cefotan In Plastic ContainerEQ 20MG BASE/ML · injectable;injection | Cefotetan Disodium | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 1995 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 9, 1995 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1993 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
