Details for New Drug Application (NDA): 062535
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NDA 062535 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-four 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-four suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 062535
| Tradename: | TOBREX |
| Applicant: | Sandoz |
| Ingredient: | tobramycin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 062535
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBREX | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 062535 | ANDA | RPK Pharmaceuticals, Inc. | 53002-9232 | 53002-9232-1 | 5 mL in 1 BOTTLE, DROPPER (53002-9232-1) |
| TOBREX | tobramycin | SOLUTION/DROPS;OPHTHALMIC | 062535 | ANDA | Sandoz Inc | 61314-643 | 61314-643-05 | 5 mL in 1 BOTTLE, PLASTIC (61314-643-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
| Approval Date: | Dec 13, 1984 | TE: | AT | RLD: | No | ||||
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