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FDA ANDA · ANDA074874

PENTOXIFYLLINE

Sponsor: PLIVA

APPLICATION
ANDA074874
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-25
LATEST ACTION
2002-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PENTOXIFYLLINEDiscontinued
PENTOXIFYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-11-18Manufacturing (CMC) · Supplement 7AP
2002-11-18Manufacturing (CMC) · Supplement 5AP
2002-11-18Manufacturing (CMC) · Supplement 3AP
2002-11-18Labeling · Supplement 8AP
2002-11-18Manufacturing (CMC) · Supplement 6AP
2002-11-18Manufacturing (CMC) · Supplement 4AP
2000-07-07Manufacturing (CMC) · Supplement 2AP
1999-06-21Labeling · Supplement 1AP
1999-05-25Original — Letter ↗AP
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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