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Generated: December 12, 2017

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:1
Applicant:1
Ingredient:1
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 54868-5442-2 60 TABLET in 1 BOTTLE (54868-5442-2)
PROAMATINE midodrine hydrochloride TABLET;ORAL 019815 NDA Physicians Total Care, Inc. 54868-5442 54868-5442-1 90 TABLET in 1 BOTTLE (54868-5442-1)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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