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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 211813


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NDA 211813 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 211813
Tradename:LINEZOLID
Applicant:Hetero Labs
Ingredient:linezolid
Patents:0
Pharmacology for NDA: 211813
Medical Subject Heading (MeSH) Categories for 211813
Suppliers and Packaging for NDA: 211813
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid FOR SUSPENSION;ORAL 211813 ANDA Camber Pharmaceuticals, Inc. 31722-865 31722-865-25 1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS
LINEZOLID linezolid FOR SUSPENSION;ORAL 211813 ANDA American Health Packaging 60687-754 60687-754-05 1 BOTTLE, GLASS in 1 CARTON (60687-754-05) / 150 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Oct 31, 2022TE:ABRLD:No

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