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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205179

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NDA 205179 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 205179

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

Pharmacology for NDA: 205179

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 205179

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 205179 ANDA Akorn, Inc. 17478-114 17478-114-30 1 VIAL, MULTI-DOSE in 1 CARTON (17478-114-30) > 30 mL in 1 VIAL, MULTI-DOSE
TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 205179 ANDA Akorn, Inc. 17478-114 17478-114-02 25 VIAL, MULTI-DOSE in 1 CARTON (17478-114-02) > 2 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Sep 16, 2014TE:APRLD:No


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