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FDA ANDA · ANDA213306

VALGANCICLOVIR HYDROCHLORIDE

valganciclovir

Sponsor: GRANULES

APPLICATION
ANDA213306
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-31
LATEST ACTION
2022-06-29
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2022-06-29Labeling · Supplement 3 · standardAP
2022-06-29Labeling · Supplement 1 · standardAP
2020-01-31UNKNOWN · Original · standardAP
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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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