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FDA ANDA · ANDA078518

VALACYCLOVIR HYDROCHLORIDE

valacyclovir

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA078518
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-24
LATEST ACTION
2023-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-05-11Labeling · Supplement 6 · standardAP
2015-03-13Manufacturing (CMC) · Supplement 1AP
2013-05-31Labeling · Supplement 3 · standardAP
2010-05-24OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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