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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
US Army
Fish and Richardson
Farmers Insurance
Argus Health

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063116

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NDA 063116 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: 063116

Formulation / Manufacturing:see details

Pharmacology for NDA: 063116


Suppliers and Packaging for NDA: 063116

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tobramycin sulfate
INJECTABLE;INJECTION 063116 ANDA Hospira, Inc. 0409-3590 0409-3590-02 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-3590-02) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 18, 1992TE:RLD:No

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Serving 500+ biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Argus Health
Fish and Richardson
Farmers Insurance
Harvard Business School
Express Scripts

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