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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 two suppliers. 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. Six suppliers are listed for this compound. Additional details are available on the disopyramide phosphate profile page.

Summary for NDA: 018655

Tradename:
NORPACE CR
Applicant:
Gd Searle Llc
Ingredient:
disopyramide phosphate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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, GELATIN COATED 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, GELATIN COATED in 1 BOX, UNIT-DOSE (0025-2732-34)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Jul 20, 1982TE:RLD:No

Summary for product number 002

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


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