Details for New Drug Application (NDA): 020947
✉ Email this page to a colleague
NDA 020947 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 020947
| Tradename: | PENNSAID |
| Applicant: | Nuvo Pharms Inc |
| Ingredient: | diclofenac sodium |
| Patents: | 4 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 4, 2009 | 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 MEDICATION ON THE SAME KNEE | ||||||||
| 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. | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 9, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT | ||||||||
Complete Access Available with Subscription
