APPLICATION
ANDA065397
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-30
LATEST ACTION
2021-06-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-06-04Labeling · Supplement 32 · standardAP
2020-08-19Labeling · Supplement 27 · standardAP
2020-08-19Labeling · Supplement 19 · standardAP
2020-08-19Labeling · Supplement 25 · standardAP
2020-08-19Labeling · Supplement 17 · standardAP
2020-08-19Labeling · Supplement 28 · standardAP
2020-08-19Labeling · Supplement 16 · standardAP
2020-08-19Labeling · Supplement 20 · standardAP
2010-11-30Manufacturing (CMC) · Supplement 3AP
2009-06-23Labeling · Supplement 2AP
2009-05-29Labeling · Supplement 1AP
2008-12-30OriginalAP
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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