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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Novartis
Julphar
Accenture
Chinese Patent Office
Farmers Insurance
Healthtrust
US Department of Justice
Fish and Richardson
Mallinckrodt

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203383

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NDA 203383 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 203383
Tradename:DICLOFENAC SODIUM
Applicant:Altaire Pharms Inc
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203383
Suppliers and Packaging for NDA: 203383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 203383 ANDA Altaire Pharmaceuticals Inc. 59390-149 59390-149-02 1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) > 2.5 mL in 1 BOTTLE, DROPPER
DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 203383 ANDA Altaire Pharmaceuticals Inc. 59390-149 59390-149-05 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Nov 16, 2015TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
US Army
Citi
Daiichi Sankyo
Medtronic
Accenture
McKinsey
Merck
Fuji

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