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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Fish and Richardson
Boehringer Ingelheim
Express Scripts

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070346

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NDA 070346 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 070346
Applicant:Par Pharm
Ingredient:amiloride hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 070346
Medical Subject Heading (MeSH) Categories for 070346
Suppliers and Packaging for NDA: 070346
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET;ORAL 070346 ANDA Par Pharmaceutical, Inc. 49884-117 N 49884-117-01
AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET;ORAL 070346 ANDA Par Pharmaceutical, Inc. 49884-117 N 49884-117-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 22, 1986TE:ABRLD:No

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