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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 075191


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NDA 075191 describes PENTOXIFYLLINE, which is a drug marketed by Ani Pharms, Apotex, Heritage Pharms, Impax Labs, Pliva, Rising, and Valeant Pharms, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the PENTOXIFYLLINE profile page.

The generic ingredient in PENTOXIFYLLINE is pentoxifylline. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pentoxifylline profile page.
Summary for 075191
Tradename:PENTOXIFYLLINE
Applicant:Apotex
Ingredient:pentoxifylline
Patents:0
Pharmacology for NDA: 075191
Physiological EffectHematologic Activity Alteration
Suppliers and Packaging for NDA: 075191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTOXIFYLLINE pentoxifylline TABLET, EXTENDED RELEASE;ORAL 075191 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8305 0615-8305-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8305-39)
PENTOXIFYLLINE pentoxifylline TABLET, EXTENDED RELEASE;ORAL 075191 ANDA Major Pharmaceuticals 0904-5448 0904-5448-61 100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Jun 9, 1999TE:ABRLD:No

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