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Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063100

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NDA 063100 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 063100
Applicant:Teva Pharms Usa
Ingredient:tobramycin sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 063100
Suppliers and Packaging for NDA: 063100
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063100 ANDA Teva Parenteral Medicines, Inc. 0703-9402 N 0703-9402-04
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063100 ANDA Teva Parenteral Medicines, Inc. 0703-9416 N 0703-9416-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Jan 30, 1992TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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