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FDA ANDA · ANDA204360

VANCOMYCIN HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA204360
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-15
LATEST ACTION
2021-05-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2021-05-25Labeling · Supplement 9 · standardAP
2020-08-27Labeling · Supplement 1 · standardAP
2018-10-15UNKNOWN · 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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