APPLICATION
ANDA074556
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-22
LATEST ACTION
2009-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
ACYCLOVIRPrescription
ACYCLOVIR 800MG · TABLET · ORAL
ACYCLOVIRDiscontinued
ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ACYCLOVIRPrescription
ACYCLOVIR 400MG · TABLET · ORAL
Approval history
2009-02-09Labeling · Supplement 19AP
2005-04-20Labeling · Supplement 13AP
2002-01-25Manufacturing (CMC) · Supplement 9AP
2002-01-25Manufacturing (CMC) · Supplement 10AP
2000-08-22Labeling · Supplement 8AP
2000-03-31Manufacturing (CMC) · Supplement 5AP
2000-03-31Manufacturing (CMC) · Supplement 6AP
2000-03-31Manufacturing (CMC) · Supplement 4AP
1998-09-09Labeling · Supplement 3AP
1997-12-16Manufacturing (CMC) · Supplement 2AP
1997-12-16Manufacturing (CMC) · Supplement 1AP
1997-04-22OriginalAP
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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