APPLICATION
ANDA212890
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-13
LATEST ACTION
2022-08-22
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
VALGANCICLOVIR HYDROCHLORIDEPrescription
VALGANCICLOVIR HYDROCHLORIDE 50MG/ML · FOR SOLUTION · ORAL
Approval history
2022-08-22Labeling · Supplement 4 · standardAP
2022-08-22Labeling · Supplement 11 · standardAP
2020-01-13UNKNOWN · 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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