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Details for New Drug Application (NDA): 204623

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NDA 204623 describes PENNSAID, which is a drug marketed by Horizon Pharma and Nuvo Res Inc and is included in two NDAs. It is available from four suppliers. There are eighteen 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. Seventy-nine suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for NDA: 204623

Tradename:
PENNSAID
Applicant:
Horizon Pharma
Ingredient:
diclofenac sodium
Patents:18
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204623

Suppliers and Packaging for NDA: 204623

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL 204623 NDA Horizon Pharma Inc. 75987-040 75987-040-05 112 g in 1 BOTTLE, PUMP (75987-040-05)
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL 204623 NDA Horizon Pharma Inc. 75987-040 75987-040-74 2 g in 1 POUCH (75987-040-74)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2%
Approval Date:Jan 16, 2014TE:RLD:Yes
Patent:9,168,304Patent Expiration:Oct 17, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,546,450Patent 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:8,741,956Patent Expiration:Jul 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.


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