Details for New Drug Application (NDA): 062535
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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 062535
Tradename: | TOBREX |
Applicant: | Sandoz |
Ingredient: | tobramycin |
Patents: | 0 |
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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