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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021324

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

The generic ingredient in ENTOCORT EC 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 021324

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: 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 0186-0702-10 100 CAPSULE in 1 BOTTLE (0186-0702-10)
ENTOCORT EC
budesonide
CAPSULE;ORAL 021324 NDA AstraZeneca Pharmaceuticals LP 0186-0702 0186-0702-94 6 CAPSULE in 1 BOTTLE (0186-0702-94)

Summary 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 Orange Book Patents for NDA: 021324

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl
ENTOCORT EC
budesonide
CAPSULE;ORAL021324-001Oct 2, 2001► Subscribe► Subscribe
Perrigo Pharma Intl
ENTOCORT EC
budesonide
CAPSULE;ORAL021324-001Oct 2, 2001► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
Citi
Merck
AstraZeneca
QuintilesIMS
Fish and Richardson
Fuji
Boehringer Ingelheim
US Department of Justice
Cipla

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