Details for New Drug Application (NDA): 019583
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The generic ingredient in RELAFEN is nabumetone. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 019583
Tradename: | RELAFEN |
Applicant: | Smithkline Beecham |
Ingredient: | nabumetone |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 24, 1991 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 24, 1991 | TE: | RLD: | Yes |
Expired US Patents for NDA 019583
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Smithkline Beecham | RELAFEN | nabumetone | TABLET;ORAL | 019583-002 | Dec 24, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Smithkline Beecham | RELAFEN | nabumetone | TABLET;ORAL | 019583-001 | Dec 24, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Smithkline Beecham | RELAFEN | nabumetone | TABLET;ORAL | 019583-002 | Dec 24, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Smithkline Beecham | RELAFEN | nabumetone | TABLET;ORAL | 019583-001 | Dec 24, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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