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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 019834

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NDA 019834 describes PLENDIL, which is a drug marketed by Astrazeneca and is included in one NDA. Additional details are available on the PLENDIL profile page.

The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.

Summary for 019834

Tradename:	PLENDIL
Applicant:	Astrazeneca
Ingredient:	felodipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019834

Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 25, 1991	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 25, 1991	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 22, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 019834

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991	4,264,611*PED	⤷ Get Started Free
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994	4,264,611*PED	⤷ Get Started Free
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991	4,803,081*PED	⤷ Get Started Free
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991	4,803,081*PED	⤷ Get Started Free
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991	4,264,611*PED	⤷ Get Started Free
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994	4,803,081*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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