ANDA 213059, held by Knack. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 213059 (Vancomycin Hydrochloride), held by Knack, was first approved by FDA on Feb 15, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 15, 2022 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 500MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| Vancomycin HydrochlorideEQ 750MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
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
