APPLICATION
ANDA074836
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-22
LATEST ACTION
2006-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACYCLOVIRDiscontinued
ACYCLOVIR 400MG · TABLET · ORAL
ACYCLOVIRDiscontinued
ACYCLOVIR 800MG · TABLET · ORAL
Approval history
2006-08-17Labeling · Supplement 28AP
2005-03-14Labeling · Supplement 26AP
2002-11-05Manufacturing (CMC) · Supplement 17AP
2002-07-29Manufacturing (CMC) · Supplement 18AP
2002-03-12Manufacturing (CMC) · Supplement 16AP
2001-09-12Manufacturing (CMC) · Supplement 15AP
2001-01-04Labeling · Supplement 14AP
2000-12-21Manufacturing (CMC) · Supplement 12AP
2000-06-07Manufacturing (CMC) · Supplement 10AP
2000-06-07Labeling · Supplement 13AP
2000-01-28Manufacturing (CMC) · Supplement 11AP
1999-06-15Manufacturing (CMC) · Supplement 7AP
1999-06-15Manufacturing (CMC) · Supplement 8AP
1999-06-15Manufacturing (CMC) · Supplement 6AP
1999-06-15Manufacturing (CMC) · Supplement 4AP
1999-02-09Manufacturing (CMC) · Supplement 2AP
1999-01-08Labeling · Supplement 9AP
1998-12-09Manufacturing (CMC) · Supplement 3AP
1998-02-25Manufacturing (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.
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.