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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Johnson and Johnson
Harvard Business School

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076449

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NDA 076449 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Impax Pharms, Mylan Pharms Inc, and Sandoz, and is included in four NDAs. It is available from fifteen suppliers. Additional details are available on the MIDODRINE HYDROCHLORIDE profile page.

The generic ingredient in MIDODRINE HYDROCHLORIDE 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 076449
Applicant:Impax Pharms
Ingredient:midodrine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076449
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 076449
Suppliers and Packaging for NDA: 076449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 076449 ANDA Impax Generics 0115-4211 N 0115-4211-02
MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 076449 ANDA Impax Generics 0115-4211 N 0115-4211-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:May 27, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 27, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 16, 2005TE:ABRLD:No

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Argus Health

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