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Details for New Drug Application (NDA): 075229

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NDA 075229 describes DICLOFENAC POTASSIUM, which is a drug marketed by Teva, Sandoz, Bionpharma Inc, Watson Labs, Apotex, Mylan, Par Form, and Sun Pharm Inds, 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-three suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for NDA: 075229

diclofenac potassium
Therapeutic Class:Analgesics
Anti-inflammatory Agents

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
TABLET;ORAL 075229 ANDA Sandoz Inc 0781-5017 0781-5017-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5017-01)
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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