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FDA ANDA · ANDA065453

VANCOMYCIN HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA065453
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-18
LATEST ACTION
2013-07-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE · CAPSULE · ORAL
VANCOMYCIN HYDROCHLORIDEDiscontinued
VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE · CAPSULE · ORAL

Approval history

2013-07-31Labeling · Supplement 1 · standardAP
2012-06-18OriginalAP
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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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