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Generated: November 21, 2018

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Details for New Drug Application (NDA): 076725

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NDA 076725 describes ORVATEN, which is a drug marketed by Upsher-smith Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the ORVATEN profile page.

The generic ingredient in ORVATEN is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 076725
Tradename:ORVATEN
Applicant:Upsher-smith Labs
Ingredient:midodrine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076725
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 076725
Suppliers and Packaging for NDA: 076725
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORVATEN midodrine hydrochloride TABLET;ORAL 076725 ANDA Upsher-Smith laboratories, LLC 0245-0211 0245-0211-11 100 TABLET in 1 BOTTLE (0245-0211-11)
ORVATEN midodrine hydrochloride TABLET;ORAL 076725 ANDA Upsher-Smith laboratories, LLC 0245-0212 0245-0212-01 100 BLISTER PACK in 1 CARTON (0245-0212-01) > 1 TABLET in 1 BLISTER PACK (0245-0212-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 3, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 3, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 3, 2004TE:ABRLD:No

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