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Generated: December 16, 2017

DrugPatentWatch Database Preview

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 three 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. Seventeen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.

Summary for 076725

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
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 0245-0212-11 100 TABLET in 1 BOTTLE (0245-0212-11)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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