Details for New Drug Application (NDA): 050789
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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 050789
Tradename: | TOBRAMYCIN SULFATE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 050789
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 050789 | NDA | Fresenius Kabi USA, LLC | 63323-303 | 63323-303-55 | 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-55) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-21) |
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 050789 | NDA | Fresenius Kabi USA, LLC | 63323-303 | 63323-303-51 | 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.2GM BASE/VIAL | ||||
Approval Date: | Jul 13, 2004 | TE: | AP | RLD: | No |
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