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

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
Fuji
AstraZeneca
Fish and Richardson
US Department of Justice
Deloitte
Cerilliant
Colorcon

Generated: August 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021324

« Back to Dashboard

NDA 021324 describes ENTOCORT EC, which is a drug marketed by Perrigo Pharma Intl and is included in one NDA. It is available from three suppliers. Additional details are available on the ENTOCORT EC profile page.

The generic ingredient in ENTOCORT EC 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 021324
Tradename:ENTOCORT EC
Applicant:Perrigo Pharma Intl
Ingredient:budesonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021324
Medical Subject Heading (MeSH) Categories for 021324
Suppliers and Packaging for NDA: 021324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTOCORT EC budesonide CAPSULE;ORAL 021324 NDA AstraZeneca Pharmaceuticals LP 0186-0702 N 0186-0702-10
ENTOCORT EC budesonide CAPSULE;ORAL 021324 NDA AstraZeneca Pharmaceuticals LP 0186-0702 N 0186-0702-94

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength3MG
Approval Date:Oct 2, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Apr 29, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING MAINTENANCE OF REMISSION IN CROHN'S DISEASE IN PEDIATRIC PATIENTS
Regulatory Exclusivity Expiration:Apr 29, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021324

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl ENTOCORT EC budesonide CAPSULE;ORAL 021324-001 Oct 2, 2001 ➤ Sign Up ➤ Sign Up
Perrigo Pharma Intl ENTOCORT EC budesonide CAPSULE;ORAL 021324-001 Oct 2, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
US Department of Justice
Mallinckrodt
QuintilesIMS
Fish and Richardson
Julphar
Healthtrust
Boehringer Ingelheim

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.