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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200068

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NDA 200068 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 200068
Tradename:LINEZOLID
Applicant:West-ward Pharms Int
Ingredient:linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 200068
Ingredient-typeOxazolidinones
Medical Subject Heading (MeSH) Categories for 200068
Suppliers and Packaging for NDA: 200068
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid FOR SUSPENSION;ORAL 200068 ANDA West-Ward Pharmaceuticals Corp. 0054-0319 N 0054-0319-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Jun 3, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Fuji
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Cipla
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Healthtrust
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