Details for New Drug Application (NDA): 050555
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The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Thirty-five 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 |
Formulation / Manufacturing: | see details |
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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