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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 019614


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NDA 019614 describes VERELAN, which is a drug marketed by Societal Cdmo and is included in two NDAs. It is available from three 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-four suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.
Summary for 019614
Tradename:VERELAN
Applicant:Societal Cdmo
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
Societal Cdmo VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-001 May 29, 1990 See Plans and Pricing See Plans and Pricing
Societal Cdmo VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-004 May 10, 1996 See Plans and Pricing See Plans and Pricing
Societal Cdmo VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-002 May 29, 1990 See Plans and Pricing See Plans and Pricing
Societal Cdmo VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-003 Jan 9, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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