Details for New Drug Application (NDA): 020584
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NDA 020584 describes LODINE XL, which is a drug marketed by Wyeth Pharms Inc and is included in one NDA. Additional details are available on the LODINE XL profile page.
The generic ingredient in LODINE XL is etodolac. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
The generic ingredient in LODINE XL is etodolac. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Summary for 020584
| Tradename: | LODINE XL |
| Applicant: | Wyeth Pharms Inc |
| Ingredient: | etodolac |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020584
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 25, 1996 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 25, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 20, 1998 | TE: | RLD: | No | |||||
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