ANDA 202634, held by Pharmobedient. Capreomycin Sulfate.
As of Nov 15, 2026, ANDA 202634 (Capreomycin Sulfate), held by Pharmobedient, was first approved by FDA on Nov 27, 2017, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Capreomycin SulfateEQ 1GM BASE/VIAL · injectable;injection | Capreomycin Sulfate | Discontinued |
| Nov 27, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 17, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 27, 2017 | Original application | 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
