APPLICATION
ANDA206876
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-12
LATEST ACTION
2022-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE EQ 450MG BASE · TABLET · ORAL
Approval history
2022-05-13Labeling · Supplement 2 · standardAP
2022-05-13Labeling · Supplement 3 · standardAP
2019-09-23Labeling · Supplement 1 · standardAP
2017-12-12UNKNOWN · 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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