APPLICATION
ANDA062476
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-21
LATEST ACTION
2021-05-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-05-24Labeling · Supplement 28 · standardAP
2020-08-18Labeling · Supplement 26 · standardAP
2020-08-18Labeling · Supplement 27 · standardAP
1996-06-24Labeling · Supplement 20AP
1996-04-24Labeling · Supplement 19AP
1995-05-24Labeling · Supplement 16AP
1994-03-04Labeling · Supplement 17AP
1993-01-11Labeling · Supplement 15AP
1992-04-28Labeling · Supplement 12AP
1992-02-28Labeling · Supplement 13AP
1986-03-21OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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