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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 017447


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NDA 017447 describes NORPACE, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. Additional details are available on the NORPACE profile page.

The generic ingredient in NORPACE is disopyramide phosphate. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the disopyramide phosphate profile page.
Summary for 017447
Tradename:NORPACE
Applicant:Pfizer
Ingredient:disopyramide phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017447
Medical Subject Heading (MeSH) Categories for 017447
Suppliers and Packaging for NDA: 017447
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORPACE disopyramide phosphate CAPSULE;ORAL 017447 NDA Pfizer Laboratories Div Pfizer Inc 0025-2752 0025-2752-31 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2752-31)
NORPACE disopyramide phosphate CAPSULE;ORAL 017447 NDA Pfizer Laboratories Div Pfizer Inc 0025-2762 0025-2762-31 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2762-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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