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Details for New Drug Application (NDA): 019614

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

The generic ingredient in VERELAN 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: 019614

Tradename:
VERELAN
Applicant:
Recro Gainesville
Ingredient:
verapamil hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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 Actavis Pharma, 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 Actavis Pharma, Inc. 0591-2882 0591-2882-01 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2882-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:May 29, 1990TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:May 29, 1990TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Jan 9, 1992TE:ABRLD:No

Expired Orange Book Patents for NDA: 019614

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recro Gainesville
VERELAN
verapamil hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019614-001May 29, 19904,863,742► subscribe
Recro Gainesville
VERELAN
verapamil hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019614-004May 10, 19964,863,742► subscribe
Recro Gainesville
VERELAN
verapamil hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019614-002May 29, 19904,863,742► subscribe
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