APPLICATION
ANDA079137
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-29
LATEST ACTION
2025-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALACYCLOVIR HYDROCHLORIDEPrescription
VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE · TABLET · ORAL
VALACYCLOVIR HYDROCHLORIDEPrescription
VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE · TABLET · ORAL
Approval history
2025-03-14Labeling · Supplement 1 · standardAP
2017-12-29OriginalAP
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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