APPLICATION
ANDA075677
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-28
LATEST ACTION
2026-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ACYCLOVIRPrescription
ACYCLOVIR 200MG · CAPSULE · ORAL
Approval history
2026-01-22Labeling · Supplement 12 · standardAP
2006-03-06Labeling · Supplement 1AP
2005-09-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.