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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065013

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NDA 065013 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 065013

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065013

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 065013

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065013 ANDA X-GEN Pharmaceuticals, Inc. 39822-0409 39822-0409-6 6 CARTON in 1 CARTON (39822-0409-6) > 1 VIAL in 1 CARTON (39822-0409-1) > 30 mL in 1 VIAL
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065013 ANDA X-GEN Pharmaceuticals, Inc. 39822-0412 39822-0412-1 1 VIAL in 1 CARTON (39822-0412-1) > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.2GM BASE/VIAL
Approval Date:Aug 17, 2001TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Julphar
McKesson
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Farmers Insurance
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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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