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Generated: January 17, 2019

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Details for New Drug Application (NDA): 070101

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NDA 070101 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 070101
Ingredient:disopyramide phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 070101
Medical Subject Heading (MeSH) Categories for 070101
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)
DISOPYRAMIDE PHOSPHATE disopyramide phosphate CAPSULE;ORAL 070101 ANDA AvKARE, Inc. 42291-234 42291-234-01 100 CAPSULE in 1 BOTTLE (42291-234-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Feb 22, 1985TE:ABRLD:No

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