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FDA ANDA · ANDA074727

ACYCLOVIR

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA074727
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-22
LATEST ACTION
2009-12-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ACYCLOVIRDiscontinued
ACYCLOVIR 200MG · CAPSULE · ORAL

Approval history

2009-12-07Labeling · Supplement 12AP
2004-10-21Labeling · Supplement 8AP
2002-07-31Labeling · Supplement 6AP
2002-03-13Labeling · Supplement 5AP
2000-11-30Manufacturing (CMC) · Supplement 4AP
1999-08-05Manufacturing (CMC) · Supplement 3AP
1998-06-08Manufacturing (CMC) · Supplement 1AP
1998-03-31Labeling · Supplement 2AP
1997-04-22OriginalReviewAP
VIEW ON DRUGS@FDA ↗

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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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