APPLICATION
ANDA216331
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-31
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
ACYCLOVIRPrescription
ACYCLOVIR 200MG/5ML · SUSPENSION · ORAL
Approval history
2026-07-01Labeling · Supplement 1 · standardAP
2022-03-31UNKNOWN · 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.
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.