Last Updated: November 8, 2026

Details for New Drug Application (NDA): 018631

NDA 018631 describes TRENTAL, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the TRENTAL profile page.

The generic ingredient in TRENTAL is pentoxifylline. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the pentoxifylline profile page.

Summary for 018631

Tradename:	TRENTAL
Applicant:	Validus Pharms
Ingredient:	pentoxifylline
Patents:	0

Pharmacology for NDA: 018631

Physiological Effect	Hematologic Activity Alteration

Medical Subject Heading (MeSH) Categories for 018631

Free Radical Scavengers
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 018631

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631	NDA	Validus Pharmaceuticals LLC	30698-006	30698-006-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (30698-006-01)
TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631	NDA	Validus Pharmaceuticals LLC	30698-006	30698-006-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (30698-006-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Aug 30, 1984	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018631

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631-001	Aug 30, 1984	3,737,433	⤷ Start Trial
Validus Pharms	TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631-001	Aug 30, 1984	4,189,469	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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