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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Healthtrust
Fuji
Mallinckrodt
Cipla
Baxter
Harvard Business School
Merck
US Army

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075281

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NDA 075281 describes DICLOFENAC SODIUM, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Glenmark Pharms Ltd, Taro, Tolmar, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising Pharms Inc, Sandoz Inc, Anda Repository, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Watson Labs Inc, Actavis Elizabeth, Allied Pharma Inc, Carlsbad, Casi Pharms Inc, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Actavis Labs Fl Inc, Exela Holdings, and Sandoz, and is included in forty-two NDAs. It is available from sixty-three suppliers. Additional details are available on the DICLOFENAC SODIUM profile page.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 075281
Tradename:DICLOFENAC SODIUM
Applicant:Mylan Pharms Inc
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075281
Suppliers and Packaging for NDA: 075281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281 ANDA Mylan Pharmaceuticals Inc. 0378-6280 N 0378-6280-01
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281 ANDA Mylan Pharmaceuticals Inc. 0378-6280 N 0378-6280-10

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG
Approval Date:Feb 12, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG
Approval Date:Feb 12, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cipla
Argus Health
Medtronic
Deloitte
US Department of Justice
Baxter
Harvard Business School
Citi

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