APPLICATION
ANDA075382
TYPE
ANDA
ORIGINAL APPROVAL
1999-04-30
LATEST ACTION
2005-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACYCLOVIRPrescription
ACYCLOVIR 800MG · TABLET · ORAL
ACYCLOVIRPrescription
ACYCLOVIR 400MG · TABLET · ORAL
Approval history
2005-09-16Labeling · Supplement 6AP
2003-04-25Labeling · Supplement 3AP
2002-09-19Manufacturing (CMC) · Supplement 2AP
2000-11-16Labeling · 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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