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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Citi
US Army
Teva
Johnson and Johnson
Healthtrust
Novartis
Fuji
McKinsey

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203818

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NDA 203818 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 eighty 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. Seventeen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 203818
Tradename:DICLOFENAC SODIUM
Applicant:Taro
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203818
Suppliers and Packaging for NDA: 203818
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 203818 ANDA Pharmaceutica North America, Inc 45861-062 45861-062-05 1 BOTTLE, DROPPER in 1 CARTON (45861-062-05) > 150 mL in 1 BOTTLE, DROPPER
DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 203818 ANDA Pharmaceutica North America, Inc 45861-066 45861-066-03 2 BOTTLE, DROPPER in 1 CARTON (45861-066-03) > 150 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength1.5%
Approval Date:Nov 26, 2014TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Teva
Daiichi Sankyo
McKinsey
Farmers Insurance
Cerilliant
QuintilesIMS
UBS
Cipla

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