APPLICATION
ANDA091554
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-19
LATEST ACTION
2021-04-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-04-07Labeling · Supplement 14 · standardAP
2021-04-07Labeling · Supplement 15 · standardAP
2020-08-19Labeling · Supplement 6 · standardAP
2020-08-19Labeling · Supplement 13 · standardAP
2020-08-19Labeling · Supplement 11 · standardAP
2014-11-07Labeling · Supplement 5 · standardAP
2011-09-19OriginalAP
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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