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-seven suppliers are listed for this compound. Additional details are available on the diclofenac sodium 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-seven 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| Dosage: | SOLUTION;TOPICAL | Strength | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | 8,217,078 | 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: | 8,252,838 | 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: | 8,546,450 | 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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