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Details for New Drug Application (NDA): 078845

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NDA 078845 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: 078845

Tradename:
LINEZOLID
Applicant:
Mylan Pharms Inc
Ingredient:
linezolid
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 078845

Ingredient-typeOxazolidinones

Suppliers and Packaging for NDA: 078845

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID
linezolid
TABLET;ORAL 078845 ANDA Mylan Pharmaceuticals Inc. 0378-7077 0378-7077-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7077-01)
LINEZOLID
linezolid
TABLET;ORAL 078845 ANDA Mylan Pharmaceuticals Inc. 0378-7077 0378-7077-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7077-05)

Summary for product number 001

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


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