Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Medtronic
Mallinckrodt
Johnson and Johnson
McKinsey

Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065122

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 065122 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 seven 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. Seven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 065122
Tradename:TOBRAMYCIN SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:tobramycin sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065122
Suppliers and Packaging for NDA: 065122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065122 ANDA Fresenius Kabi USA, LLC 63323-305 63323-305-02 25 VIAL, MULTI-DOSE in 1 TRAY (63323-305-02) > 2 mL in 1 VIAL, MULTI-DOSE
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065122 ANDA Fresenius Kabi USA, LLC 63323-306 63323-306-02 25 VIAL, MULTI-DOSE in 1 TRAY (63323-306-02) > 2 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Nov 29, 2002TE:APRLD:No

Profile for product number 002

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Baxter
AstraZeneca
Medtronic
Express Scripts

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.