APPLICATION
ANDA210401
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-07
LATEST ACTION
2026-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACYCLOVIRPrescription
ACYCLOVIR 800MG · TABLET · ORAL
ACYCLOVIRPrescription
ACYCLOVIR 400MG · TABLET · ORAL
Approval history
2026-06-24Labeling · Supplement 5 · standardAP
2018-03-07UNKNOWN · 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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