Details for New Drug Application (NDA): 017604
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The generic ingredient in NALFON is fenoprofen calcium. There are nine drug master file entries for this compound. Seven 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 AUTHORIZED GENERIC | Gentex Pharma | 15014-400 | 15014-400-60 | 60 CAPSULE in 1 BOTTLE (15014-400-60) |
NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604 | NDA AUTHORIZED GENERIC | Gentex Pharma | 15014-400 | 15014-400-90 | 90 CAPSULE in 1 BOTTLE (15014-400-90) |
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Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | ⤷ Sign Up | ⤷ Sign Up |
Key Therap | NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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