Treats serious or severe infections caused by susceptible strains of…. ANDA 62912, held by Hospira. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 62912 (Vancomycin Hydrochloride), held by Hospira, was first approved by FDA on Aug 4, 1988, with 18 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 1988 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 750MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 1.5GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| May 24, 2021 | Supplement 81Labeling · Standard review | Approved | None posted |
| Sep 1, 2020 | Supplement 74Labeling · Standard review | Approved | None posted |
| Sep 1, 2020 | Supplement 52Labeling · Standard review | Approved | None posted |
| Apr 13, 2017 | Supplement 58Labeling · Standard review | Approved | None posted |
| Jun 12, 2012 | Supplement 49Labeling | Approved | |
| Nov 30, 2011 | Supplement 40Labeling | Approved | |
| Jan 7, 2009 | Supplement 39Labeling | Approved | |
| Jan 7, 2009 | Supplement 38Manufacturing | Approved | |
| Aug 21, 2008 | Supplement 16Labeling | Approved | None posted |
| Oct 4, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Feb 1, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Jun 14, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Jul 14, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Nov 13, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Oct 22, 1993 | Supplement 5Manufacturing | Approved | None posted |
| Jul 23, 1991 | Supplement 4Manufacturing | Approved | None posted |
| Dec 5, 1988 | Supplement 2Manufacturing | Approved | None posted |
| Dec 5, 1988 | Supplement 1Manufacturing | Approved | None posted |
| Aug 4, 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
