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Federal Trade Commission
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Generated: December 11, 2017

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, 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 NDAs. It is available from twenty-five 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. Thirty-three suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for 200068

Tradename:1
Applicant:1
Ingredient:1
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 0054-0319-50 150 mL in 1 BOTTLE (0054-0319-50)

Summary for product number 001

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


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