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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 205517


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NDA 205517 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 Pharms, 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 205517
Tradename:LINEZOLID
Applicant:Alkem Labs Ltd
Ingredient:linezolid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205517
Medical Subject Heading (MeSH) Categories for 205517
Suppliers and Packaging for NDA: 205517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 205517 ANDA Major Pharmaceuticals 0904-6553 0904-6553-04 30 BLISTER PACK in 1 CARTON (0904-6553-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
LINEZOLID linezolid TABLET;ORAL 205517 ANDA Ascend Laboratories, LLC 67877-419 67877-419-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-419-01)

Profile for product number 001

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

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