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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 sixteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

Summary for NDA: 020943

Tradename:
VERELAN PM
Applicant:
Recro Gainesville
Ingredient:
verapamil hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
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 Kremers Urban Pharmaceuticals 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 Kremers Urban Pharmaceuticals Inc. 62175-486 62175-486-37 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62175-486-37)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Nov 25, 1998TE:ABRLD:No

Summary for product number 003

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

Expired Orange Book 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;ORAL020943-001Nov 25, 19984,863,742► subscribe
Recro Gainesville
VERELAN PM
verapamil hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020943-003Nov 25, 19984,863,742► subscribe
Recro Gainesville
VERELAN PM
verapamil hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020943-002Nov 25, 19984,863,742► subscribe
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