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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065407

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NDA 065407 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 065407
Applicant:Mylan Labs Ltd
Ingredient:tobramycin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 065407
Suppliers and Packaging for NDA: 065407
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065407 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0088 E 0069-0088-02
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065407 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0091 E 0069-0091-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Mar 11, 2008TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health

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