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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207354


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NDA 207354 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 207354
Tradename:LINEZOLID
Applicant:Nang Kuang Pharm Co
Ingredient:linezolid
Patents:0
Pharmacology for NDA: 207354
Medical Subject Heading (MeSH) Categories for 207354
Suppliers and Packaging for NDA: 207354
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid SOLUTION;INTRAVENOUS 207354 ANDA Sun Pharmaceutical Industries, Inc. 57664-682 57664-682-30 100 mL in 1 BAG (57664-682-30)
LINEZOLID linezolid SOLUTION;INTRAVENOUS 207354 ANDA Sun Pharmaceutical Industries, Inc. 57664-683 57664-683-57 10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/100ML (2MG/ML)
Approval Date:Dec 20, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength600MG/300ML (2MG/ML)
Approval Date:Dec 20, 2016TE:APRLD:No

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