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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 five suppliers. Additional details are available on the ENTOCORT EC profile page.

The generic ingredient in ENTOCORT EC is budesonide. There are nineteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 021324

Pharmacology for NDA: 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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl
ENTOCORT EC
budesonide
CAPSULE;ORAL021324-001Oct 2, 20015,643,602*PED► subscribe
Perrigo Pharma Intl
ENTOCORT EC
budesonide
CAPSULE;ORAL021324-001Oct 2, 20016,423,340*PED► subscribe
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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.

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