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FDA ANDA · ANDA090370

VALACYCLOVIR HYDROCHLORIDE

Sponsor: WATSON LABS INC

APPLICATION
ANDA090370
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-16
LATEST ACTION
2020-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VALACYCLOVIR HYDROCHLORIDEDiscontinued
VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE · TABLET · ORAL
VALACYCLOVIR HYDROCHLORIDEDiscontinued
VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL

Approval history

2020-03-12Labeling · Supplement 9 · standardAP
2011-03-16OriginalAP
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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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