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Generated: November 15, 2018

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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 four 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-one suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.
Summary for 019614
Tradename:VERELAN
Applicant:Recro Gainesville
Ingredient:verapamil hydrochloride
Patents:0
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:May 29, 1990TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength240MG
Approval Date:May 29, 1990TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Jan 9, 1992TE:ABRLD:Yes

Expired US Patents for NDA 019614

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recro Gainesville VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-001 May 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Recro Gainesville VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-004 May 10, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Recro Gainesville VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-002 May 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Recro Gainesville VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-003 Jan 9, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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