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Last Updated: January 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018655

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NDA 018655 describes NORPACE CR, which is a drug marketed by Gd Searle Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NORPACE CR profile page.

The generic ingredient in NORPACE CR is disopyramide phosphate. There are nineteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the disopyramide phosphate profile page.
Summary for 018655
Tradename:NORPACE CR
Applicant:Gd Searle Llc
Ingredient:disopyramide phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018655
Medical Subject Heading (MeSH) Categories for 018655
Suppliers and Packaging for NDA: 018655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORPACE CR disopyramide phosphate CAPSULE, EXTENDED RELEASE;ORAL 018655 NDA G.D. Searle LLC Division of Pfizer Inc 0025-2732 0025-2732-31 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31)
NORPACE CR disopyramide phosphate CAPSULE, EXTENDED RELEASE;ORAL 018655 NDA G.D. Searle LLC Division of Pfizer Inc 0025-2732 0025-2732-34 100 CAPSULE, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0025-2732-34)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Jul 20, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:Jul 20, 1982TE:RLD:Yes

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