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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
US Army
Argus Health
Queensland Health
Moodys
Federal Trade Commission
Daiichi Sankyo
Covington

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078202

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NDA 078202 describes BUDESONIDE, which is a drug marketed by Alvogen Malta, Amneal Pharms, Appco Pharma Llc, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms Usa Inc, Apotex Inc, Cipla Ltd, Impax Labs Inc, Sandoz Inc, Teva Pharms, and Teva Pharms Usa, and is included in fifteen NDAs. It is available from thirty-one suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-one drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 078202
Pharmacology for NDA: 078202
Medical Subject Heading (MeSH) Categories for 078202
Suppliers and Packaging for NDA: 078202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide SUSPENSION;INHALATION 078202 ANDA Nephron SC Inc. 0487-9601 N 0487-9601-01
BUDESONIDE budesonide SUSPENSION;INHALATION 078202 ANDA Nephron SC Inc. 0487-9601 N 0487-9601-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Mar 30, 2009TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Mar 30, 2009TE:ANRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Queensland Health
Harvard Business School
AstraZeneca
Fish and Richardson
Deloitte
Medtronic
McKesson
Cipla

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