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DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075191

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NDA 075191 describes PENTOXIFYLLINE, which is a drug marketed by Watson Labs, Mylan, Valeant Pharms, Pliva, Heritage Pharms Inc, Actavis Elizabeth, Apotex, Impax Labs, and Teva, and is included in nine NDAs. It is available from twenty-two 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. Twenty-two suppliers are listed for this compound. Additional details are available on the pentoxifylline profile page.

Summary for NDA: 075191


Pharmacology for NDA: 075191

Suppliers and Packaging for NDA: 075191

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, EXTENDED RELEASE;ORAL 075191 ANDA Major Pharmaceuticals 0904-5448 0904-5448-61 100 TABLET, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0904-5448-61)
TABLET, EXTENDED RELEASE;ORAL 075191 ANDA Aidarex Pharmaceuticals LLC 33261-992 33261-992-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-992-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Jun 9, 1999TE:ABRLD:Yes

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