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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 070101

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NDA 070101 describes DISOPYRAMIDE PHOSPHATE, which is a drug marketed by Nesher Pharms, Dr Reddys Labs Sa, Interpharm, Ivax Sub Teva Pharms, Mylan, Rising, Sun Pharm Industries, Superpharm, Teva, and Watson Labs, and is included in eighteen NDAs. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the disopyramide phosphate profile page.

Summary for 070101

Tradename:	DISOPYRAMIDE PHOSPHATE
Applicant:	Teva
Ingredient:	disopyramide phosphate
Patents:	0

Pharmacology for NDA: 070101

Medical Subject Heading (MeSH) Categories for 070101

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 070101

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DISOPYRAMIDE PHOSPHATE	disopyramide phosphate	CAPSULE;ORAL	070101	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3127	0093-3127-01	100 CAPSULE in 1 BOTTLE (0093-3127-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Feb 22, 1985	TE:	AB	RLD:	No

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