APPLICATION
ANDA075211
TYPE
ANDA
ORIGINAL APPROVAL
1998-09-28
LATEST ACTION
2026-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACYCLOVIRPrescription
ACYCLOVIR 800MG · TABLET · ORAL
ACYCLOVIRPrescription
ACYCLOVIR 400MG · TABLET · ORAL
Approval history
2026-06-05Labeling · Supplement 16 · standardAP
2009-12-07Labeling · Supplement 9AP
2004-10-21Labeling · Supplement 6AP
2002-07-31Labeling · Supplement 4AP
2002-03-13Labeling · Supplement 3AP
2001-04-18Manufacturing (CMC) · Supplement 2AP
1999-07-23Manufacturing (CMC) · Supplement 1AP
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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