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Serving 500+ biopharmaceutical companies globally:

Chubb
Argus Health
Healthtrust
Julphar
Dow
Colorcon
Johnson and Johnson
Cipla
US Army
Fish and Richardson

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065122

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NDA 065122 describes TOBRAMYCIN SULFATE, which is a drug marketed by Teva Pharms Usa, Mylan Labs Ltd, Hospira, West-ward Pharms Int, X Gen Pharms, Igi Labs Inc, Apothecon, Fresenius Kabi Usa, Watson Labs Inc, Claris, Akorn, 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 NDA: 065122

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 065122

Ingredient-typeAminoglycosides

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 63323-306-55 25 VIAL in 1 TRAY (63323-306-55) > 2 mL in 1 VIAL

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Cerilliant
US Army
Mallinckrodt
Novartis
Chubb
Merck
Cipla
Julphar
Boehringer Ingelheim

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.

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