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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077746

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NDA 077746 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Casi Pharms 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. Seventeen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.

Summary for 077746

Tradename:	MIDODRINE HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	midodrine hydrochloride
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077746

Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for 077746

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 077746

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	077746	ANDA	AvKARE, Inc.	42291-560	N	42291-560-90
MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	077746	ANDA	AvKARE, Inc.	42291-561	N	42291-561-90

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 12, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 12, 2006	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 12, 2006	TE:	AB	RLD:	No

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