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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 019614

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NDA 019614 describes VERELAN, which is a drug marketed by Societal Cdmo and is included in two NDAs. It is available from three suppliers. Additional details are available on the VERELAN profile page.

The generic ingredient in VERELAN is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for 019614

Tradename:	VERELAN
Applicant:	Societal Cdmo
Ingredient:	verapamil hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019614

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 019614

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 019614

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614	NDA	Teva Pharmaceuticals Inc	0591-2880	0591-2880-01	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2880-01)
VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614	NDA	Teva Pharmaceuticals Inc	0591-2882	0591-2882-01	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2882-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	May 29, 1990	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	May 29, 1990	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Jan 9, 1992	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019614

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Societal Cdmo	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-002	May 29, 1990	⤷ Try a Trial	⤷ Try a Trial
Societal Cdmo	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-004	May 10, 1996	⤷ Try a Trial	⤷ Try a Trial
Societal Cdmo	VERELAN	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019614-001	May 29, 1990	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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