FDA ANDA · ANDA205220

VALGANCICLOVIR HYDROCHLORIDE FOR ORAL

valganciclovir hydrochloride

Sponsor: ACTAVIS LABS FL INC

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APPLICATION
ANDA205220
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-18
LATEST ACTION
2026-10-19
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE 50MG/ML · FOR SOLUTION · ORAL

Approval history

2026-10-19Manufacturing (CMC) · Supplement 17 · unknownAP
2020-03-12Labeling · Supplement 4 · standardAP
2020-03-12Labeling · Supplement 2 · standardAP
2016-07-18UNKNOWN · Original · standard — Letter ↗AP