APPLICATION
ANDA062812
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-17
LATEST ACTION
2021-05-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
VANCOCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2021-05-24Labeling · Supplement 34 · standardAP
2020-08-18Labeling · Supplement 33 · standardAP
2017-07-12Labeling · Supplement 32 · standardAP
2017-07-12Labeling · Supplement 30 · standardAP
2017-07-12Labeling · Supplement 31 · standardAP
1996-06-20Manufacturing (CMC) · Supplement 22AP
1996-04-24Labeling · Supplement 23AP
1994-03-04Labeling · Supplement 20AP
1993-01-12Labeling · Supplement 19AP
1992-11-03Labeling · Supplement 13AP
1991-11-08Labeling · Supplement 18AP
1987-11-17OriginalAP
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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