ANDA 62879, held by Hikma. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 62879 (Vancomycin Hydrochloride), held by Hikma, was first approved by FDA on Aug 2, 1988, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 1988 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 500MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| Jun 11, 2021 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jun 11, 2021 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 15, 1996 | Supplement 16Manufacturing | Approved | None posted |
| Dec 15, 1995 | Supplement 15Manufacturing | Approved | None posted |
| Dec 30, 1994 | Supplement 12Labeling | Approved | None posted |
| Aug 18, 1994 | Supplement 13Manufacturing | Approved | None posted |
| Aug 19, 1993 | Supplement 11Manufacturing | Approved | None posted |
| Jul 27, 1992 | Supplement 9Labeling | Approved | None posted |
| Jul 27, 1992 | Supplement 4Manufacturing | Approved | None posted |
| Feb 28, 1992 | Supplement 10Manufacturing | Approved | None posted |
| Nov 9, 1990 | Supplement 8Manufacturing | Approved | None posted |
| Mar 27, 1990 | Supplement 7Manufacturing | Approved | None posted |
| Feb 26, 1990 | Supplement 5Manufacturing | Approved | None posted |
| Feb 26, 1990 | Supplement 2Manufacturing | Approved | None posted |
| Dec 1, 1988 | Supplement 3Manufacturing | Approved | None posted |
| Aug 2, 1988 | Original application | 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
