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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204623


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NDA 204623 describes PENNSAID, which is a drug marketed by Horizon and Nuvo Pharms Inc and is included in two NDAs. It is available from six 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. One hundred and twenty-nine suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 204623
Tradename:PENNSAID
Applicant:Horizon
Ingredient:diclofenac sodium
Patents:19
Pharmacology for NDA: 204623
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
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 AUTHORIZED GENERIC Proficient Rx LP 71205-821 71205-821-12 1 BOTTLE, PUMP in 1 CARTON (71205-821-12) / 112 g in 1 BOTTLE, PUMP
PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623 NDA AUTHORIZED GENERIC Direct_Rx 72189-498 72189-498-04 112 g in 1 BOTTLE (72189-498-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 16, 2014TE:RLD:Yes
Patent:⤷  Sign UpPatent 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:⤷  Sign UpPatent Expiration:Apr 21, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
Patent:⤷  Sign UpPatent 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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