APPLICATION
ANDA074870
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-05
LATEST ACTION
2004-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACYCLOVIRDiscontinued
ACYCLOVIR 800MG · TABLET · ORAL
ACYCLOVIRDiscontinued
ACYCLOVIR 400MG · TABLET · ORAL
Approval history
2004-10-28Labeling · Supplement 9AP
2002-04-23Labeling · Supplement 5AP
2001-11-02Manufacturing (CMC) · Supplement 4AP
2000-07-17Labeling · Supplement 3AP
1998-08-10Labeling · Supplement 2AP
1998-03-26Labeling · 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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