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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Julphar
Deloitte
US Army
Boehringer Ingelheim
Cantor Fitzgerald
Harvard Business School
Medtronic
AstraZeneca
Cerilliant
Chinese Patent Office

Generated: December 15, 2017

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 nine 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. Nine suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for 050789

Tradename:1
Applicant:1
Ingredient:1
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 63323-303-51 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) > 30 mL in 1 VIAL, PHARMACY BULK 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

Summary 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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Serving leading biopharmaceutical companies globally:

McKesson
Fuji
QuintilesIMS
Healthtrust
Citi
Moodys
Colorcon
Queensland Health
Mallinckrodt
Cipla

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