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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Fish and Richardson
McKesson
Harvard Business School
Moodys
Healthtrust
Express Scripts
Baxter
Novartis

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019815

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NDA 019815 describes PROAMATINE, which is a drug marketed by Shire Llc and is included in one NDA. It is available from one supplier. Additional details are available on the PROAMATINE profile page.

The generic ingredient in PROAMATINE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 019815
Tradename:PROAMATINE
Applicant:Shire Llc
Ingredient:midodrine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019815
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 019815
Suppliers and Packaging for NDA: 019815
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROAMATINE midodrine hydrochloride TABLET;ORAL 019815 NDA Physicians Total Care, Inc. 54868-5442 E 54868-5442-2
PROAMATINE midodrine hydrochloride TABLET;ORAL 019815 NDA Physicians Total Care, Inc. 54868-5442 E 54868-5442-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 6, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Sep 6, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Mar 20, 2002TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
McKinsey
Boehringer Ingelheim
Express Scripts
Teva
Chubb
Julphar
Medtronic
Colorcon

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