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Serving 500+ biopharmaceutical companies globally:

Accenture
Dow
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Cipla
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Fish and Richardson
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Generated: August 17, 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 Hq Spclt Pharma, 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, Nang Kuang Pharm Co, Teva Pharms Usa, Fresenius Kabi Usa, West-ward Pharms Int, Glenmark Pharms, Sagent Pharms, and Zydus Pharms Usa Inc, and is included in twenty NDAs. It is available from twenty-three 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-one suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for NDA: 078987

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

Pharmacology for NDA: 078987

Ingredient-typeOxazolidinones

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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Serving 500+ biopharmaceutical companies globally:

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