Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Dow
UBS
US Department of Justice
Harvard Business School
Colorcon
Covington
Julphar
Deloitte

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065120

« Back to Dashboard

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
Tradename:TOBRAMYCIN SULFATE (PHARMACY BULK)
Applicant:Fresenius Kabi Usa
Ingredient:tobramycin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065120
Ingredient-typeAminoglycosides
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 N 63323-307-51

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Nov 29, 2002TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
Citi
Argus Health
Fish and Richardson
Colorcon
Baxter
Mallinckrodt
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.