Details for New Drug Application (NDA): 065120
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The generic ingredient in TOBRAMYCIN SULFATE (PHARMACY BULK) 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 065120
Tradename: | TOBRAMYCIN SULFATE (PHARMACY BULK) |
Applicant: | Fresenius Kabi Usa |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 065120
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE (PHARMACY BULK) | tobramycin sulfate | INJECTABLE;INJECTION | 065120 | ANDA | Fresenius Kabi USA, LLC | 63323-307 | 63323-307-51 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-307-51) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
Approval Date: | Nov 29, 2002 | TE: | AP | RLD: | No |
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