APPLICATION
ANDA063076
TYPE
ANDA
ORIGINAL APPROVAL
1990-12-21
LATEST ACTION
2021-05-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-05-24Labeling · Supplement 43 · standardAP
2020-09-01Labeling · Supplement 39 · standardAP
2020-09-01Labeling · Supplement 27 · standardAP
2020-09-01Labeling · Supplement 30 · standardAP
2011-11-30Labeling · Supplement 18AP
2005-07-25Labeling · Supplement 10AP
2002-10-04Manufacturing (CMC) · Supplement 7AP
2002-02-01Manufacturing (CMC) · Supplement 6AP
2001-06-14Manufacturing (CMC) · Supplement 5AP
1998-12-09Manufacturing (CMC) · Supplement 4AP
1996-11-18Manufacturing (CMC) · Supplement 3AP
1995-10-25Manufacturing (CMC) · Supplement 2AP
1990-12-21OriginalAP
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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