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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078987

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NDA 078987 describes LINEZOLID, which is a drug marketed by West-ward Pharms Int, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Nang Kuang Pharm Co, Sagent Pharms, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan Pharms Inc, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in twenty NDAs. It is available from twenty-five 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. Thirty-three suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for 078987

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 078987

Ingredient-typeOxazolidinones

Medical Subject Heading (MeSH) Categories for 078987

Suppliers and Packaging for NDA: 078987

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINEZOLID linezolid TABLET;ORAL 078987 ANDA Glenmark Pharmaceuticals Inc., USA 68462-291 68462-291-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-291-01)
LINEZOLID linezolid TABLET;ORAL 078987 ANDA Glenmark Pharmaceuticals Inc., USA 68462-291 68462-291-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-291-05)

Summary for product number 001

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


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