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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Queensland Health

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079133

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NDA 079133 describes AMILORIDE HYDROCHLORIDE, which is a drug marketed by Par Pharm, Sigmapharm Labs Llc, Windlas Hlthcare, Barr, Mylan, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the AMILORIDE HYDROCHLORIDE profile page.

The generic ingredient in AMILORIDE HYDROCHLORIDE is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.
Summary for 079133
Applicant:Sigmapharm Labs Llc
Ingredient:amiloride hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079133
Medical Subject Heading (MeSH) Categories for 079133
Suppliers and Packaging for NDA: 079133
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET;ORAL 079133 ANDA AvKARE, Inc. 42291-122 N 42291-122-90
AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET;ORAL 079133 ANDA AvPAK 50268-071 N 50268-071-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 30, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
Cantor Fitzgerald
Express Scripts
Queensland Health

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