Details for New Drug Application (NDA): 017604
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NDA 017604 describes NALFON, which is a drug marketed by Key Therap and Dista and is included in two NDAs. It is available from three suppliers. Additional details are available on the NALFON profile page.
The generic ingredient in NALFON is fenoprofen calcium. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
The generic ingredient in NALFON is fenoprofen calcium. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.
Summary for 017604
| Tradename: | NALFON |
| Applicant: | Key Therap |
| Ingredient: | fenoprofen calcium |
| Patents: | 0 |
Pharmacology for NDA: 017604
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 017604
Suppliers and Packaging for NDA: 017604
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604 | NDA | Misemer Pharmaceuticals, Inc. | 0276-0502 | 0276-0502-10 | 100 CAPSULE in 1 BOTTLE (0276-0502-10) |
| NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604 | NDA | Misemer Pharmaceuticals, Inc. | 0276-0503 | 0276-0503-90 | 90 CAPSULE in 1 BOTTLE (0276-0503-90) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Jul 21, 2009 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 017604
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Key Therap | NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604-002 | Approved Prior to Jan 1, 1982 | 3,600,437 | ⤷ Try for Free |
| Key Therap | NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604-003 | Approved Prior to Jan 1, 1982 | 3,600,437 | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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