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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Harvard Business School
US Department of Justice
Boehringer Ingelheim
Express Scripts
US Army
McKinsey
Queensland Health
AstraZeneca

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074376

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NDA 074376 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, Mylan Pharms Inc, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Actavis Labs Fl Inc, and Exela Holdings, and is included in forty-two NDAs. It is available from seventy-eight 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. Sixteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 074376
Tradename:DICLOFENAC SODIUM
Applicant:Sandoz
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074376
Suppliers and Packaging for NDA: 074376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074376 ANDA Sandoz Inc 0781-1785 N 0781-1785-10
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074376 ANDA Sandoz Inc 0781-1785 N 0781-1785-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength25MG
Approval Date:Sep 28, 1995TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG
Approval Date:Sep 28, 1995TE:ABRLD:No

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