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FDA ANDA · ANDA074578

ACYCLOVIR

Sponsor: TEVA

APPLICATION
ANDA074578
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-22
LATEST ACTION
2009-02-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ACYCLOVIRPrescription
ACYCLOVIR 200MG · CAPSULE · ORAL

Approval history

2009-02-09Labeling · Supplement 13AP
2005-04-20Labeling · Supplement 9AP
2002-01-25Manufacturing (CMC) · Supplement 7AP
2002-01-25Manufacturing (CMC) · Supplement 6AP
2000-08-22Labeling · Supplement 5AP
1998-09-30Manufacturing (CMC) · Supplement 3AP
1998-09-09Labeling · Supplement 2AP
1997-12-09Manufacturing (CMC) · Supplement 1AP
1997-04-22OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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