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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076514

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NDA 076514 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: 076514

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076514

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 076514

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride
TABLET;ORAL 076514 ANDA Eon Labs, Inc. 0185-0040 0185-0040-01 100 TABLET in 1 BOTTLE (0185-0040-01)
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride
TABLET;ORAL 076514 ANDA Eon Labs, Inc. 0185-0040 0185-0040-05 500 TABLET in 1 BOTTLE (0185-0040-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 11, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 11, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 2, 2004TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Fuji
Express Scripts
Argus Health
Farmers Insurance
Daiichi Sankyo
Chubb
US Department of Justice
Boehringer Ingelheim

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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