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FDA ANDA · ANDA075191

PENTOXIFYLLINE

Sponsor: APOTEX

APPLICATION
ANDA075191
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-09
LATEST ACTION
2017-03-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

PENTOXIFYLLINEPrescription
PENTOXIFYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-03-29Labeling · Supplement 18 · standardAP
2015-07-31Labeling · Supplement 13 · standardAP
2015-07-31Labeling · Supplement 16 · standardAP
2015-07-31Labeling · Supplement 14 · standardAP
2001-06-18Manufacturing (CMC) · Supplement 6AP
2001-06-18Manufacturing (CMC) · Supplement 4AP
2001-06-18Manufacturing (CMC) · Supplement 2AP
2001-06-18Manufacturing (CMC) · Supplement 7AP
2001-06-18Manufacturing (CMC) · Supplement 5AP
2001-06-18Manufacturing (CMC) · Supplement 3AP
2000-01-24Manufacturing (CMC) · Supplement 1AP
1999-06-09Original — 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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