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Serving 500+ biopharmaceutical companies globally:

Teva
Baxter
Cipla
Fuji
Accenture
Deloitte
Novartis
US Army
Mallinckrodt
Merck

Generated: June 24, 2017

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 Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Falcon Pharms, Actavis Elizabeth, Amneal Pharms, Taro, Teva, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, Akorn, Watson Labs Inc, Mylan, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Sandoz, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Allied Pharma Inc, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Twi Pharms Inc, Exela Holdings, and Actavis Labs Fl Inc, and is included in forty-two NDAs. It is available from seventy-two 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. Eighteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for NDA: 203818

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Federal Trade Commission
Fish and Richardson
Moodys
AstraZeneca
Chubb
McKinsey
US Department of Justice
Dow
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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