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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 206097


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NDA 206097 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, Macleods Pharms Ltd, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-five NDAs. It is available from twenty-two 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-five suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Summary for 206097
Tradename:LINEZOLID
Applicant:Zydus Pharms
Ingredient:linezolid
Patents:0
Pharmacology for NDA: 206097
Medical Subject Heading (MeSH) Categories for 206097
Suppliers and Packaging for NDA: 206097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 206097 ANDA Zydus Pharmaceuticals USA Inc. 68382-413 68382-413-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-413-01)
LINEZOLID linezolid TABLET;ORAL 206097 ANDA Zydus Pharmaceuticals USA Inc. 68382-413 68382-413-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-413-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 22, 2017TE:ABRLD:No

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