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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Farmers Insurance

Generated: July 20, 2017

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 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. Ten suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride profile page.

Summary for NDA: 018200

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018200

Suppliers and Packaging for NDA: 018200

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amiloride hydrochloride
TABLET;ORAL 018200 NDA Paddock Laboratories, LLC 0574-0292 0574-0292-01 100 TABLET in 1 BOTTLE (0574-0292-01)
amiloride hydrochloride
TABLET;ORAL 018200 NDA Physicians Total Care, Inc. 54868-5214 54868-5214-0 60 TABLET in 1 BOTTLE, PLASTIC (54868-5214-0)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Argus Health
Fish and Richardson
US Department of Justice
Federal Trade Commission

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