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FDA ANDA · ANDA201048

VANCOMYCIN HYDROCHLORIDE

Sponsor: PLANO PHARMS

APPLICATION
ANDA201048
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-10
LATEST ACTION
2021-11-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2021-11-12Labeling · Supplement 3 · standardAP
2021-11-12Labeling · Supplement 1 · standardAP
2021-11-12Labeling · Supplement 2 · standardAP
2012-08-10Not Applicable · OriginalAP
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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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