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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204764

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NDA 204764 describes LINEZOLID, which is a drug marketed by West-ward Pharms Int, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan Pharms Inc, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in twenty-one NDAs. It is available from twenty-four suppliers. Additional details are available on the LINEZOLID profile page.

The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 204764
Tradename:LINEZOLID
Applicant:Fresenius Kabi Usa
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 204764
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 204764
Suppliers and Packaging for NDA: 204764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid SOLUTION;IV (INFUSION) 204764 ANDA Fresenius Kabi USA, LLC 63323-713 N 63323-713-13
LINEZOLID linezolid SOLUTION;IV (INFUSION) 204764 ANDA Fresenius Kabi Norge AS 66298-7131 N 66298-7131-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength600MG/300ML (2MG/ML)
Approval Date:Mar 15, 2016TE:APRLD:No

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