ANDA 62682, held by Hikma. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 62682 (Vancoled), held by Hikma, was first approved by FDA on Jul 22, 1986, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 1986 | Original application | Approved | None posted |
| VancoledEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| VancoledEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| VancoledEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| VancoledEQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| VancoledEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| Jun 11, 2021 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jun 11, 2021 | Supplement 18Labeling · Standard review | Approved | None posted |
| Oct 23, 2001 | Supplement 17Manufacturing | Approved | None posted |
| Jul 31, 2001 | Supplement 16Manufacturing | Approved | None posted |
| Jan 29, 1999 | Supplement 14Manufacturing | Approved | None posted |
| Dec 5, 1995 | Supplement 13Labeling | Approved | None posted |
| Mar 10, 1992 | Supplement 12Manufacturing | Approved | None posted |
| Sep 9, 1991 | Supplement 8Labeling | Approved | None posted |
| Apr 22, 1991 | Supplement 11Labeling | Approved | None posted |
| Mar 5, 1991 | Supplement 10Manufacturing | Approved | None posted |
| Mar 1, 1989 | Supplement 6Manufacturing | Approved | None posted |
| May 11, 1988 | Supplement 3Manufacturing | Approved | None posted |
| Mar 30, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Jul 22, 1986 | 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
