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

How our clients use DrugPatentWatch

Generated: April 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078404

« Back to Dashboard
NDA 078404 describes BUDESONIDE, which is a drug marketed by Apotex Inc, Impax Labs Inc, Mylan, Teva Pharms, Mayne Pharma, Alvogen Malta, Teva Pharms Usa, Sandoz Inc, Appco Pharma Llc, and Barr Labs Div Teva, and is included in eleven NDAs. It is available from twenty-six 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-five suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 078404

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078404

Suppliers and Packaging for NDA: 078404

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;INHALATION 078404 ANDA Impax Generics 0115-1687 0115-1687-74 6 POUCH in 1 CARTON (0115-1687-74) > 5 VIAL in 1 POUCH (0115-1687-76) > 2 mL in 1 VIAL
SUSPENSION;INHALATION 078404 ANDA Impax Generics 0115-1689 0115-1689-74 6 POUCH in 1 CARTON (0115-1689-74) > 5 VIAL in 1 POUCH (0115-1689-76) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Jul 31, 2012TE:ANRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Jul 31, 2012TE: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

How our clients use DrugPatentWatch

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

Follow DrugPatentWatch:

Google Plus