APPLICATION
ANDA065401
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2021-04-30
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-04-30Labeling · Supplement 16 · standardAP
2020-10-19Labeling · Supplement 14 · standardAP
2020-10-19Labeling · Supplement 12 · standardAP
2020-10-19Labeling · Supplement 15 · standardAP
2013-04-26Labeling · Supplement 4AP
2009-06-23Labeling · Supplement 2AP
2008-06-30OriginalAP
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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