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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075229

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NDA 075229 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 075229

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075229

Suppliers and Packaging for NDA: 075229

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229 ANDA Sandoz Inc 0781-5017 0781-5017-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5017-01)
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075229 ANDA Sandoz Inc 0781-5017 0781-5017-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5017-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 20, 1998TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
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Fish and Richardson
Express Scripts
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