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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050789

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NDA 050789 describes TOBRAMYCIN SULFATE, which is a drug marketed by Akorn, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Teva Pharms Usa, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in twenty-seven NDAs. It is available from eight suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.

The generic ingredient in TOBRAMYCIN SULFATE 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 050789
Tradename:TOBRAMYCIN SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:tobramycin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050789
Ingredient-typeAminoglycosides
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 N 63323-303-51
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 050789 NDA Fresenius Kabi USA, LLC 63323-303 N 63323-303-55

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.2GM BASE/VIAL
Approval Date:Jul 13, 2004TE:APRLD:No

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