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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 two suppliers. Additional details are available on the PROAMATINE profile page.

The generic ingredient in PROAMATINE is midodrine hydrochloride. There are twelve 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 NDA: 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

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 Shire US Manufacturing Inc. 54092-003 54092-003-01 100 TABLET in 1 BOTTLE (54092-003-01)
PROAMATINE
midodrine hydrochloride
TABLET;ORAL 019815 NDA Shire US Manufacturing Inc. 54092-004 54092-004-01 100 TABLET in 1 BOTTLE (54092-004-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 6, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Sep 6, 1996TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Mar 20, 2002TE:RLD:No


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