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Generated: December 10, 2018

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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 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. Thirty-nine 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 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)

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

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