Details for New Drug Application (NDA): 050605
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NDA 050605 describes CEFTIN, which is a drug marketed by Glaxosmithkline and is included in two NDAs. Additional details are available on the CEFTIN profile page.
The generic ingredient in CEFTIN is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
The generic ingredient in CEFTIN is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
Summary for 050605
| Tradename: | CEFTIN |
| Applicant: | Glaxosmithkline |
| Ingredient: | cefuroxime axetil |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 28, 1987 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 28, 1987 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 28, 1987 | TE: | RLD: | Yes | |||||
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