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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Boehringer Ingelheim
Chinese Patent Office
Express Scripts

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202964

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NDA 202964 describes DICLOFENAC POTASSIUM, which is a drug marketed by Bionpharma Inc, Par Form, Apotex, Mylan, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in nine NDAs. It is available from twenty suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.

The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 202964
Applicant:Par Form
Ingredient:diclofenac potassium
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202964
Suppliers and Packaging for NDA: 202964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964 ANDA Par Pharmaceutical Inc. 49884-905 49884-905-52 1 POWDER in 1 PACKET (49884-905-52)
DICLOFENAC POTASSIUM diclofenac potassium FOR SOLUTION;ORAL 202964 ANDA Par Pharmaceutical Inc. 49884-905 49884-905-24 3 POWDER in 1 CARTON (49884-905-24)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG
Approval Date:May 2, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
US Department of Justice
Chinese Patent Office

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