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Generated: December 15, 2017

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, 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 075219

Tradename:1
Applicant:1
Ingredient:1
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 0093-0948-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0948-05)
DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075219 ANDA Teva Pharmaceuticals USA Inc 0093-0948 0093-0948-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0948-01)

Summary for product number 001

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


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