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Generated: May 27, 2017

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Details for New Drug Application (NDA): 202845

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NDA 202845 describes DIFLUNISAL, which is a drug marketed by Watson Labs, Idt Australia Ltd, Heritage Pharma, Roxane, Teva, and Purepac Pharm, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the DIFLUNISAL profile page.

The generic ingredient in DIFLUNISAL is diflunisal. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the diflunisal profile page.

Summary for NDA: 202845

Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202845

Suppliers and Packaging for NDA: 202845

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 202845 ANDA A-S Medication Solutions 50090-0450 50090-0450-2 30 TABLET, FILM COATED in 1 BOTTLE (50090-0450-2)
TABLET;ORAL 202845 ANDA Rising Pharmaceuticals Inc. 64980-181 64980-181-01 100 TABLET, FILM COATED in 1 BOTTLE (64980-181-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 8, 2012TE:ABRLD:No

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