APPLICATION
ANDA076588
TYPE
ANDA
ORIGINAL APPROVAL
2007-01-31
LATEST ACTION
2023-03-23
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
2023-03-23Labeling · Supplement 34 · standardAP
2023-03-23Labeling · Supplement 32 · standardAP
2023-03-23Labeling · Supplement 29 · standardAP
2020-02-28Labeling · Supplement 21 · standardAP
2018-02-16Manufacturing (CMC) · Supplement 16AP
2013-05-14Labeling · Supplement 19 · standardAP
2010-07-20Labeling · Supplement 6AP
2010-07-20Labeling · Supplement 12AP
2010-07-20Labeling · Supplement 13AP
2007-01-31OriginalAP
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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