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FDA ANDA · ANDA200790

VALGANCICLOVIR

valganciclovir hydrochloride

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA200790
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-04
LATEST ACTION
2020-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE · TABLET · ORAL

Approval history

2020-03-12Labeling · Supplement 3 · standardAP
2016-04-28Labeling · Supplement 1 · standardAP
2014-11-04Not Applicable · Original — Letter ↗AP
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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