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Generated: November 18, 2018

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Details for New Drug Application (NDA): 013174

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NDA 013174 describes DYRENIUM, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the DYRENIUM profile page.

The generic ingredient in DYRENIUM is triamterene. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the triamterene profile page.
Summary for 013174
Tradename:DYRENIUM
Applicant:Concordia Pharms Inc
Ingredient:triamterene
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 013174
Medical Subject Heading (MeSH) Categories for 013174
Suppliers and Packaging for NDA: 013174
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYRENIUM triamterene CAPSULE;ORAL 013174 NDA Concordia Pharmaceuticals Inc. 59212-002 59212-002-01 100 CAPSULE in 1 BOTTLE (59212-002-01)
DYRENIUM triamterene CAPSULE;ORAL 013174 NDA Concordia Pharmaceuticals Inc. 59212-003 59212-003-01 100 CAPSULE in 1 BOTTLE (59212-003-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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