APPLICATION
ANDA090682
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-24
LATEST ACTION
2023-05-08
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
2023-05-08Labeling · Supplement 20 · standardAP
2023-05-08Labeling · Supplement 17 · standardAP
2015-08-13Labeling · Supplement 7AP
2015-01-27Manufacturing (CMC) · Supplement 9 · unknownAP
2014-10-24Manufacturing (CMC) · Supplement 8AP
2013-03-15Manufacturing (CMC) · Supplement 6AP
2010-05-24OriginalAP
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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