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FDA ANDA · ANDA074878

PENTOXIFYLLINE

Sponsor: ANI PHARMS

APPLICATION
ANDA074878
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-09
LATEST ACTION
2001-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

PENTOXIFYLLINEPrescription
PENTOXIFYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2001-11-02Manufacturing (CMC) · Supplement 10AP
2001-03-30Manufacturing (CMC) · Supplement 9AP
2000-08-28Manufacturing (CMC) · Supplement 4AP
2000-07-07Manufacturing (CMC) · Supplement 8AP
2000-02-16Manufacturing (CMC) · Supplement 7AP
2000-02-16Manufacturing (CMC) · Supplement 5AP
2000-02-16Manufacturing (CMC) · Supplement 6AP
1998-09-21Manufacturing (CMC) · Supplement 3AP
1998-03-02Manufacturing (CMC) · Supplement 1AP
1998-02-06Labeling · Supplement 2AP
1997-07-09OriginalAP
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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