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Generated: April 23, 2018

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, 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 205233
Tradename:LINEZOLID
Applicant:Alembic Pharms Ltd
Ingredient:linezolid
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 N 46708-183-30
LINEZOLID linezolid TABLET;ORAL 205233 ANDA Alembic Pharmaceuticals Limited 46708-183 N 46708-183-91

Profile for product number 001

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

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