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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 020943


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NDA 020943 describes VERELAN PM, which is a drug marketed by Recro Gainesville 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.
Summary for 020943
Tradename:VERELAN PM
Applicant:Recro Gainesville
Ingredient:verapamil hydrochloride
Patents:0
Formulation / Manufacturing:see details
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 Lannett Company, Inc. 62175-485 62175-485-37 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62175-485-37)
VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943 NDA Lannett Company, Inc. 62175-486 62175-486-37 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62175-486-37)
Paragraph IV (Patent) Challenges for 020943
Tradename Dosage Ingredient NDA Submissiondate
VERELAN PM CAPSULE, EXTENDED RELEASE;ORAL verapamil hydrochloride 020943 2006-07-20
VERELAN PM CAPSULE, EXTENDED RELEASE;ORAL verapamil hydrochloride 020943 2006-05-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Nov 25, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Nov 25, 1998TE:RLD:Yes

Expired US Patents for NDA 020943

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recro Gainesville VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943-001 Nov 25, 1998   Start Trial   Start Trial
Recro Gainesville VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943-003 Nov 25, 1998   Start Trial   Start Trial
Recro Gainesville VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943-002 Nov 25, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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