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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Fish and Richardson
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Accenture
Cerilliant

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208077

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NDA 208077 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-nine 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 208077

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 208077

Suppliers and Packaging for NDA: 208077

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077 ANDA AvKARE, Inc. 42291-256 42291-256-11 1 TUBE in 1 CARTON (42291-256-11) > 100 g in 1 TUBE
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077 ANDA Proficient Rx LP 63187-762 63187-762-00 1 TUBE in 1 CARTON (63187-762-00) > 100 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Mar 18, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
US Army
Fuji
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Harvard Business School
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Chinese Patent Office
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Novartis

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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