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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
Johnson and Johnson
Farmers Insurance
Chinese Patent Office

Generated: September 20, 2017

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 Sandoz, Apotex Inc, Impax Pharms, and Mylan Pharms Inc, 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. Eighteen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.

Summary for NDA: 076449

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076449

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 076449

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
midodrine hydrochloride
TABLET;ORAL 076449 ANDA Impax Generics 0115-4211 0115-4211-01 100 TABLET in 1 BOTTLE (0115-4211-01)
midodrine hydrochloride
TABLET;ORAL 076449 ANDA Impax Generics 0115-4211 0115-4211-02 500 TABLET in 1 BOTTLE (0115-4211-02)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Boehringer Ingelheim
Cantor Fitzgerald
Federal Trade Commission
Argus Health

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