APPLICATION
ANDA074738
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-28
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 38 · standardAP
2009-06-10Labeling · Supplement 28AP
2005-01-24Labeling · Supplement 12AP
2002-09-18Labeling · Supplement 7AP
2002-02-22Manufacturing (CMC) · Supplement 6AP
2001-06-13Labeling · Supplement 5AP
2001-01-16Manufacturing (CMC) · Supplement 3AP
2000-11-16Labeling · Supplement 4AP
1998-07-06Labeling · Supplement 2AP
1998-03-26Labeling · Supplement 1AP
1997-04-28OriginalAP
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.
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