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Serving leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
Novartis
Boehringer Ingelheim
Farmers Insurance
Medtronic
US Army
Cantor Fitzgerald
Queensland Health
Cerilliant

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020947

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NDA 020947 describes PENNSAID, which is a drug marketed by Horizon Pharma and Nuvo Pharms Inc and is included in two NDAs. It is available from two suppliers. There are nineteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PENNSAID profile page.

The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. Ninety suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 020947
Tradename:PENNSAID
Applicant:Nuvo Pharms Inc
Ingredient:diclofenac sodium
Patents:4
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020947
Suppliers and Packaging for NDA: 020947
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947 NDA STAT RX USA LLC 16590-453 16590-453-33 150 mL in 1 BOTTLE, DROPPER (16590-453-33)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 4, 2009TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Jul 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
Patent:➤ SubscribePatent Expiration:Aug 9, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
Patent:➤ SubscribePatent Expiration:Aug 9, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT

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Serving leading biopharmaceutical companies globally:

Cerilliant
Dow
UBS
Accenture
US Department of Justice
Harvard Business School
Merck
Federal Trade Commission
Boehringer Ingelheim

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