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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070173

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NDA 070173 describes DISOPYRAMIDE PHOSPHATE, which is a drug marketed by Nesher Pharms, Aurolife Pharma Llc, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma, Mylan, Sun Pharm Industries, Superpharm, Teva, and Watson Labs, and is included in eighteen NDAs. It is available from six suppliers. Additional details are available on the DISOPYRAMIDE PHOSPHATE profile page.

The generic ingredient in DISOPYRAMIDE PHOSPHATE 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 070173
Tradename:DISOPYRAMIDE PHOSPHATE
Applicant:Mayne Pharma
Ingredient:disopyramide phosphate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 070173
Medical Subject Heading (MeSH) Categories for 070173
Suppliers and Packaging for NDA: 070173
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DISOPYRAMIDE PHOSPHATE disopyramide phosphate CAPSULE;ORAL 070173 ANDA Actavis Pharma, Inc. 0591-5560 N 0591-5560-01
DISOPYRAMIDE PHOSPHATE disopyramide phosphate CAPSULE;ORAL 070173 ANDA Mayne Pharma Inc. 51862-093 N 51862-093-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:May 31, 1985TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:May 31, 1985TE:ABRLD:No

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