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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 Hospira and Fresenius Kabi Usa and is included in two NDAs. It is available from two suppliers. 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. Nine suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for NDA: 065120

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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Nov 29, 2002TE:RLD:Yes

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