APPLICATION
ANDA212234
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-26
LATEST ACTION
2022-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE · TABLET · ORAL
Approval history
2022-08-22Labeling · Supplement 19 · standardAP
2021-06-04Labeling · Supplement 9 · standardAP
2021-06-04Labeling · Supplement 7 · standardAP
2019-12-26UNKNOWN · Original · standardAP
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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