APPLICATION
ANDA074425
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-08
LATEST ACTION
2020-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PENTOXIFYLLINEPrescription
PENTOXIFYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-11-02Labeling · Supplement 24 · standardAP
2016-01-21Labeling · Supplement 22 · standardAP
2016-01-21Labeling · Supplement 21 · standardAP
2007-01-12Manufacturing (CMC) · Supplement 13AP
2005-12-12Labeling · Supplement 14AP
2004-01-21Labeling · Supplement 11AP
2000-04-19Manufacturing (CMC) · Supplement 10AP
1999-11-15Manufacturing (CMC) · Supplement 9AP
1999-11-03Labeling · Supplement 7AP
1999-11-03Manufacturing (CMC) · Supplement 8AP
1999-11-03Manufacturing (CMC) · Supplement 6AP
1999-07-22Manufacturing (CMC) · Supplement 5AP
1998-08-25Labeling · Supplement 4AP
1998-04-07Manufacturing (CMC) · Supplement 3AP
1998-04-07Manufacturing (CMC) · Supplement 2AP
1998-02-26Manufacturing (CMC) · Supplement 1AP
1997-07-08OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.