← FDA DRUG APPROVALS

FDA NDA · NDA018631

TRENTAL

Sponsor: VALIDUS PHARMS

APPLICATION
NDA018631
TYPE
NDA
ORIGINAL APPROVAL
1984-08-30
LATEST ACTION
2016-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TRENTAL · ReferenceDiscontinued
PENTOXIFYLLINE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2016-01-15Labeling · Supplement 41 · standard — Label ↗AP
2015-02-13Labeling · Supplement 40 · standard — Letter ↗AP
2014-04-17Labeling · Supplement 36 · standard — Letter ↗AP
2012-07-05Labeling · Supplement 39 · unknown — Letter ↗AP
2005-04-07Labeling · Supplement 34 · standard — Letter ↗AP
2003-09-30Labeling · Supplement 33 · standard — Letter ↗AP
1997-11-03Manufacturing (CMC) · Supplement 31 · priorityAP
1997-04-29Labeling · Supplement 30 · standard — Review ↗AP
1996-06-18Manufacturing (CMC) · Supplement 29 · priorityAP
1996-02-09Manufacturing (CMC) · Supplement 27 · priorityAP
1996-01-02Manufacturing (CMC) · Supplement 26 · priorityAP
1995-07-28Labeling · Supplement 23 · standardAP
1995-04-10Manufacturing (CMC) · Supplement 25 · priorityAP
1995-04-04Manufacturing (CMC) · Supplement 24 · priorityAP
1994-11-04Manufacturing (CMC) · Supplement 21 · priorityAP
1994-07-25Labeling · Supplement 22 · standardAP
1993-11-24Manufacturing (CMC) · Supplement 20 · priorityAP
1993-02-11Manufacturing (CMC) · Supplement 19 · priorityAP
1991-12-16Manufacturing (CMC) · Supplement 18 · priorityAP
1991-11-07Labeling · Supplement 14AP
1991-11-07Labeling · Supplement 12AP
1991-04-30Manufacturing (CMC) · Supplement 16 · priorityAP
1991-03-27Manufacturing (CMC) · Supplement 15 · priorityAP
1990-10-30Manufacturing (CMC) · Supplement 13 · priorityAP
1990-02-23Manufacturing (CMC) · Supplement 11 · priorityAP
1989-07-28Manufacturing (CMC) · Supplement 9 · priorityAP
1988-01-27Labeling · Supplement 7AP
1987-09-03Manufacturing (CMC) · Supplement 5 · priorityAP
1986-05-27Manufacturing (CMC) · Supplement 4 · priorityAP
1986-04-24Labeling · Supplement 3AP
1985-10-04Manufacturing (CMC) · Supplement 2 · priorityAP
1985-05-13Labeling · Supplement 1AP
1984-08-30Type 1 - New Molecular Entity · Original · priorityAP
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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