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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075679

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NDA 075679 describes KETOPROFEN, which is a drug marketed by Heritage Pharms Inc, Teva, Aurolife Pharma Llc, Mylan, Perrigo, Actavis Labs Fl Inc, and Alkermes Gainesville, and is included in ten NDAs. It is available from seventeen suppliers. Additional details are available on the KETOPROFEN profile page.

The generic ingredient in KETOPROFEN is ketoprofen. There are twenty-seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.

Summary for NDA: 075679

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

Pharmacology for NDA: 075679

Suppliers and Packaging for NDA: 075679

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE, EXTENDED RELEASE;ORAL 075679 ANDA Mylan Pharmaceuticals Inc. 0378-8200 0378-8200-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)
CAPSULE, EXTENDED RELEASE;ORAL 075679 ANDA Physicians Total Care, Inc. 54868-4826 54868-4826-0 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4826-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Feb 20, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Feb 20, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Feb 20, 2002TE:ABRLD:No

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