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Details for New Drug Application (NDA): 077746

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NDA 077746 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 fourteen 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 NDA: 077746

Apotex Inc
midodrine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077746

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 077746

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
midodrine hydrochloride
TABLET;ORAL 077746 ANDA Apotex Corp 60505-1320 60505-1320-1 100 TABLET in 1 BOTTLE (60505-1320-1)
midodrine hydrochloride
TABLET;ORAL 077746 ANDA Apotex Corp 60505-1320 60505-1320-3 30 TABLET in 1 BOTTLE (60505-1320-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 12, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 12, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 12, 2006TE:ABRLD:No

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