Details for New Drug Application (NDA): 204623
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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 Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased 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: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jan 16, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 10, 2029 | Product 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 Up | Patent Expiration: | Apr 21, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 9, 2030 | Product 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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