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Generated: September 19, 2018

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Details for New Drug Application (NDA): 018817

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NDA 018817 describes CALAN, which is a drug marketed by Gd Searle Llc and Pfizer and is included in three NDAs. It is available from one supplier. Additional details are available on the CALAN profile page.

The generic ingredient in CALAN 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 018817
Tradename:CALAN
Applicant:Gd Searle Llc
Ingredient:verapamil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018817
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALAN verapamil hydrochloride TABLET;ORAL 018817 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1851 0025-1851-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1851-31)
CALAN verapamil hydrochloride TABLET;ORAL 018817 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1861 0025-1861-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1861-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Sep 10, 1984TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Sep 10, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:Feb 23, 1988TE:RLD:No

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