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Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018200

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NDA 018200 describes MIDAMOR, which is a drug marketed by Paddock Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the MIDAMOR profile page.

The generic ingredient in MIDAMOR is amiloride hydrochloride. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride profile page.
Summary for 018200
Applicant:Paddock Llc
Ingredient:amiloride hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 018200
Medical Subject Heading (MeSH) Categories for 018200
Suppliers and Packaging for NDA: 018200
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAMOR amiloride hydrochloride TABLET;ORAL 018200 NDA KAISER FOUNDATION HOSPITALS 0179-0230 N 0179-0230-70
MIDAMOR amiloride hydrochloride TABLET;ORAL 018200 NDA Paddock Laboratories, LLC 0574-0292 N 0574-0292-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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