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Last Updated: December 2, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200068

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NDA 200068 describes LINEZOLID, which is a drug marketed by Hikma Pharms, Eugia Pharma, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Celltrion, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-two NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 200068
Applicant:Hikma Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 200068
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 Hikma Pharmaceuticals USA Inc. 0054-0319 0054-0319-50 150 mL in 1 BOTTLE (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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