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Generated: April 25, 2019

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Details for New Drug Application (NDA): 065120

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NDA 065120 describes TOBRAMYCIN SULFATE (PHARMACY BULK), which is a drug marketed by Fresenius Kabi Usa and Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the TOBRAMYCIN SULFATE (PHARMACY BULK) profile page.

The generic ingredient in TOBRAMYCIN SULFATE (PHARMACY BULK) is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 065120
Applicant:Fresenius Kabi Usa
Ingredient:tobramycin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 065120
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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Nov 29, 2002TE:RLD:No

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