Details for New Drug Application (NDA): 050555
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NDA 050555 describes TOBREX, which is a drug marketed by Novartis and Sandoz and is included in three NDAs. It is available from five 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 050555
| Tradename: | TOBREX |
| Applicant: | Novartis |
| Ingredient: | tobramycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050555
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBREX | tobramycin | OINTMENT;OPHTHALMIC | 050555 | NDA | Novartis Pharmaceuticals Corporation | 0078-0813 | 0078-0813-01 | 3.5 g in 1 TUBE (0078-0813-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.3% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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