Details for New Drug Application (NDA): 050541
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NDA 050541 describes TOBREX, which is a drug marketed by Novartis and Sandoz and is included in three NDAs. It is available from four suppliers. Additional details are available on the TOBREX profile page.
The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050541
| Tradename: | TOBREX |
| Applicant: | Novartis |
| Ingredient: | tobramycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050541
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Yes | |||||
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