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Queensland Health
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075219

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NDA 075219 describes DICLOFENAC POTASSIUM, which is a drug marketed by Bionpharma Inc, Par Form, Apotex, Casi Pharms Inc, Mylan, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in nine NDAs. It is available from nineteen 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-one suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 075219
Tradename:DICLOFENAC POTASSIUM
Applicant:Teva
Ingredient:diclofenac potassium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075219
Suppliers and Packaging for NDA: 075219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075219 ANDA Teva Pharmaceuticals USA Inc 0093-0948 N 0093-0948-01
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075219 ANDA Teva Pharmaceuticals USA Inc 0093-0948 N 0093-0948-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 6, 1998TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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