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FDA ANDA · ANDA204107

VANCOMYCIN HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA204107
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-28
LATEST ACTION
2021-09-20
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

2021-09-20Labeling · Supplement 11 · standardAP
2020-08-19Labeling · Supplement 5 · standardAP
2020-08-19Labeling · Supplement 3 · standardAP
2015-12-28UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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