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Details for New Drug Application (NDA): 204764

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NDA 204764 describes LINEZOLID, which is a drug marketed by Sandoz Inc, Gate Pharms, Aurobindo Pharma Ltd, Alkem Labs Ltd, Teva Pharms, Novel Labs Inc, Alembic Pharms Ltd, Amneal Pharms, Hetero Labs Ltd V, Hospira Inc, Mylan Pharms Inc, Teva Pharms Usa, Fresenius Kabi Usa, Roxane, and Glenmark Pharms, and is included in sixteen NDAs. It is available from eighteen 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-seven suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for NDA: 204764

Fresenius Kabi Usa
Therapeutic Class:Antibacterials

Pharmacology for NDA: 204764


Suppliers and Packaging for NDA: 204764

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;IV (INFUSION) 204764 ANDA Fresenius Kabi USA, LLC 63323-713 63323-713-13 300 mL in 1 BAG (63323-713-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength600MG/300ML (2MG/ML)
Approval Date:Mar 15, 2016TE:APRLD:No

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