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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205233

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NDA 205233 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 205233

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

Pharmacology for NDA: 205233

Ingredient-typeOxazolidinones

Medical Subject Heading (MeSH) Categories for 205233

Suppliers and Packaging for NDA: 205233

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 205233 ANDA Alembic Pharmaceuticals Limited 46708-183 46708-183-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-183-31)
LINEZOLID linezolid TABLET;ORAL 205233 ANDA Alembic Pharmaceuticals Limited 46708-183 46708-183-20 20 TABLET, FILM COATED in 1 BOTTLE (46708-183-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Dec 21, 2015TE:ABRLD:No


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