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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205233


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NDA 205233 describes LINEZOLID, which is a drug marketed by Hetero Labs, Hikma, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Speclt, Hetero Labs Ltd V, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-four NDAs. It is available from twenty-one 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 205233
Tradename:LINEZOLID
Applicant:Alembic
Ingredient:linezolid
Patents:0
Pharmacology for NDA: 205233
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 46708-183-20 20 TABLET, FILM COATED in 1 BOTTLE (46708-183-20)
LINEZOLID linezolid TABLET;ORAL 205233 ANDA Alembic Pharmaceuticals Limited 46708-183 46708-183-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-183-30)

Profile for product number 001

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

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