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McKinsey
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Federal Trade Commission
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205501

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NDA 205501 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Akorn Inc, Amneal Pharms, Lupin Atlantis, Mylan Pharms Inc, Teva Pharms Usa, Akorn, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in thirty-eight NDAs. It is available from sixteen suppliers. Additional details are available on the TOBRAMYCIN profile page.

The generic ingredient in TOBRAMYCIN 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 205501
Tradename:TOBRAMYCIN
Applicant:Amneal Pharms
Ingredient:tobramycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205501
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 205501
Suppliers and Packaging for NDA: 205501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN tobramycin SOLUTION;INHALATION 205501 ANDA Amneal Pharmaceuticals LLC 65162-914 N 65162-914-46

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength300MG/5ML
Approval Date:Jul 13, 2015TE:ANRLD:No

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