Details for New Drug Application (NDA): 020943

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NDA 020943 describes VERELAN PM, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. Additional details are available on the VERELAN PM profile page.

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

Summary for 020943

Tradename:	VERELAN PM
Applicant:	Azurity
Ingredient:	verapamil hydrochloride
Patents:	0

Pharmacology for NDA: 020943

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

Medical Subject Heading (MeSH) Categories for 020943

Anti-Arrhythmia Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 020943

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943	NDA	Chartwell RX, LLC	62135-532	62135-532-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62135-532-30)
VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943	NDA	Lannett Company, Inc.	62175-485	62175-485-37	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62175-485-37)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 25, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Nov 25, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Nov 25, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020943

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-001	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-003	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-002	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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