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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Fish and Richardson
Daiichi Sankyo
Chinese Patent Office

Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074116

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NDA 074116 describes PIROXICAM, which is a drug marketed by Mylan, Teva Pharms, Egis, Mylan Ireland Ltd, Teva, PII, SCS, Sun Pharm Inds, Flamingo Pharms, Unichem Labs Ltd, Ivax Sub Teva Pharms, Cycle Pharms Ltd, and Watson Labs, and is included in eighteen NDAs. It is available from twenty-two suppliers. Additional details are available on the PIROXICAM profile page.

The generic ingredient in PIROXICAM is desmethyl piroxicam. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desmethyl piroxicam profile page.

Summary for NDA: 074116

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

Pharmacology for NDA: 074116

Suppliers and Packaging for NDA: 074116

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 074116 ANDA Mylan Pharmaceuticals Inc. 0378-0466 0378-0466-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-0466-01)
CAPSULE;ORAL 074116 ANDA PACK Pharmaceuticals, LLC 16571-012 16571-012-01 100 CAPSULE in 1 BOTTLE, PLASTIC (16571-012-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 15, 1993TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Farmers Insurance
US Department of Justice
Johnson and Johnson
Daiichi Sankyo

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