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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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Fish and Richardson

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206917

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NDA 206917 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-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-two suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 206917
Applicant:Aurobindo Pharma Ltd
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 206917
Medical Subject Heading (MeSH) Categories for 206917
Suppliers and Packaging for NDA: 206917
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid SOLUTION;IV (INFUSION) 206917 ANDA AuroMedics Pharma LLC 55150-242 N 55150-242-51

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength600MG/300ML (2MG/ML)
Approval Date:Aug 4, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
US Department of Justice
Queensland Health
Daiichi Sankyo

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