Details for New Drug Application (NDA): 063111
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The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 063111
Tradename: | TOBRAMYCIN SULFATE |
Applicant: | Hospira |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 063111
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063111 | ANDA | Hospira, Inc. | 0409-3578 | 0409-3578-01 | 25 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01) / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
Approval Date: | Apr 30, 1991 | TE: | AP | RLD: | No |
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