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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021324

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NDA 021324 describes ENTOCORT EC, which is a drug marketed by Padagis Us 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-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 021324

Tradename:	ENTOCORT EC
Applicant:	Padagis Us
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 021324

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021324

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 021324

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324	NDA	Padagis US LLC	0574-9855	0574-9855-10	1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE
ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324	NDA	Golden State Medical Supply, Inc.	51407-591	51407-591-01	100 CAPSULE in 1 BOTTLE (51407-591-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	3MG
Approval Date:	Oct 2, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021324

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	5,643,602*PED	⤷ Get Started Free
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	6,423,340*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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