.

Make Better Decisions

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Teva
UBS
Healthtrust
Colorcon
McKinsey
McKesson
Medtronic
US Department of Justice
Merck
Mallinckrodt

Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201966

« Back to Dashboard
NDA 201966 describes BUDESONIDE, which is a drug marketed by Amneal Pharms, Apotex Inc, Impax Labs Inc, Mylan, Teva Pharms, Mayne Pharma, Alvogen Malta, Zydus Pharms Usa Inc, Sciecure Pharma Inc, Teva Pharms Usa, Sandoz Inc, Appco Pharma Llc, and Barr Labs Div Teva, and is included in fourteen NDAs. It is available from thirty suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 201966

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201966

Medical Subject Heading (MeSH) Categories for 201966

Suppliers and Packaging for NDA: 201966

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE
budesonide
SUSPENSION;INHALATION 201966 ANDA Sandoz Inc 0781-7515 0781-7515-87 6 POUCH in 1 CARTON (0781-7515-87) > 5 AMPULE in 1 POUCH (0781-7515-14) > 2 mL in 1 AMPULE
BUDESONIDE
budesonide
SUSPENSION;INHALATION 201966 ANDA Sandoz Inc 0781-7516 0781-7516-87 6 POUCH in 1 CARTON (0781-7516-87) > 5 AMPULE in 1 POUCH (0781-7516-14) > 2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength1MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Deloitte
Federal Trade Commission
Harvard Business School
Fish and Richardson
US Department of Justice
Colorcon
Moodys
Medtronic
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot