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Last Updated: July 3, 2020

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 one supplier. Additional details are available on the ENTOCORT EC profile page.

The generic ingredient in ENTOCORT EC is budesonide. There are twenty-two 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 021324
Applicant:Perrigo Pharma Intl
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 Paddock Laboratories, LLC 0574-9850 0574-9850-10 100 CAPSULE in 1 BOTTLE (0574-9850-10)
ENTOCORT EC budesonide CAPSULE;ORAL 021324 NDA Paddock Laboratories, LLC 0574-9855 0574-9855-10 1 BOTTLE in 1 CARTON (0574-9855-10) > 100 CAPSULE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021324
Tradename Dosage Ingredient NDA Submissiondate
ENTOCORT EC CAPSULE;ORAL budesonide 021324 2008-02-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength3MG
Approval Date:Oct 2, 2001TE:ABRLD:Yes

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