APPLICATION
ANDA062931
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-29
LATEST ACTION
2021-05-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-05-24Labeling · Supplement 43 · standardAP
2020-09-01Labeling · Supplement 39 · standardAP
2020-09-01Labeling · Supplement 29 · standardAP
2020-09-01Labeling · Supplement 27 · standardAP
2020-09-01Labeling · Supplement 31 · standardAP
2012-05-22Labeling · Supplement 26AP
2002-03-15Manufacturing (CMC) · Supplement 5AP
2002-02-01Manufacturing (CMC) · Supplement 9AP
2001-06-14Manufacturing (CMC) · Supplement 8AP
2001-04-09Manufacturing (CMC) · Supplement 7AP
2000-04-04Manufacturing (CMC) · Supplement 6AP
1996-11-18Manufacturing (CMC) · Supplement 4AP
1995-10-25Manufacturing (CMC) · Supplement 3AP
1995-05-10Manufacturing (CMC) · Supplement 2AP
1993-04-09Manufacturing (CMC) · Supplement 1AP
1992-10-29OriginalAP
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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