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Last Updated: March 19, 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 eleven 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-six 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
Formulation / Manufacturing:see details
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 Padagis US LLC 0574-0167 0574-0167-12 1 BOTTLE in 1 CARTON (0574-0167-12) / 112 g in 1 BOTTLE
PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-9603 63629-9603-1 1 BOTTLE in 1 CARTON (63629-9603-1) / 112 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2%
Approval Date:Jan 16, 2014TE:ABRLD:Yes
Patent:⤷  Try a 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 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 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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