APPLICATION
ANDA062879
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-02
LATEST ACTION
2021-06-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-06-11Labeling · Supplement 18 · standardAP
2021-06-11Labeling · Supplement 17 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 16AP
1995-12-15Manufacturing (CMC) · Supplement 15AP
1994-12-30Labeling · Supplement 12AP
1994-08-18Manufacturing (CMC) · Supplement 13AP
1993-08-19Manufacturing (CMC) · Supplement 11AP
1992-07-27Manufacturing (CMC) · Supplement 4AP
1992-07-27Labeling · Supplement 9AP
1992-02-28Manufacturing (CMC) · Supplement 10AP
1990-11-09Manufacturing (CMC) · Supplement 8AP
1990-03-27Manufacturing (CMC) · Supplement 7AP
1990-02-26Manufacturing (CMC) · Supplement 2AP
1990-02-26Manufacturing (CMC) · Supplement 5AP
1988-12-01Manufacturing (CMC) · Supplement 3AP
1988-08-02OriginalAP
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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