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FDA ANDA · ANDA074976

ACYCLOVIR

Sponsor: MYLAN

APPLICATION
ANDA074976
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-13
LATEST ACTION
2000-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACYCLOVIRDiscontinued
ACYCLOVIR 400MG · TABLET · ORAL
ACYCLOVIRDiscontinued
ACYCLOVIR 800MG · TABLET · ORAL

Approval history

2000-09-12Labeling · Supplement 2AP
1999-12-20Manufacturing (CMC) · Supplement 1AP
1998-04-13OriginalLabelAP
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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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