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Generated: November 13, 2018

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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 Hznp and Nuvo Pharms Inc and is included in two NDAs. It is available from one supplier. 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-three suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 204623
Tradename:PENNSAID
Applicant:Hznp
Ingredient:diclofenac sodium
Patents:19
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2%
Approval Date:Jan 16, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
Patent:➤ Try a Free TrialPatent Expiration:Apr 21, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
Patent:➤ Try a Free TrialPatent 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.

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