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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 019546

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NDA 019546 describes DYNACIRC, which is a drug marketed by Smithkline Beecham and Glaxosmithkline Llc and is included in two NDAs. Additional details are available on the DYNACIRC profile page.

The generic ingredient in DYNACIRC is isradipine. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the isradipine profile page.

Summary for 019546

Tradename:	DYNACIRC
Applicant:	Smithkline Beecham
Ingredient:	isradipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019546

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1990	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019546

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990	⤷ Get Started Free	⤷ Get Started Free
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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