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Generated: November 12, 2018

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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 two 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. Eight suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride profile page.
Summary for 018200
Tradename:MIDAMOR
Applicant:Paddock Llc
Ingredient:amiloride hydrochloride
Patents:0
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 0179-0230-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0230-70)
MIDAMOR amiloride hydrochloride TABLET;ORAL 018200 NDA Paddock Laboratories, LLC 0574-0292 0574-0292-01 100 TABLET in 1 BOTTLE (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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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