Last Updated: May 3, 2026

Details for New Drug Application (NDA): 076449

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NDA 076449 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Ph Health, Rubicon Research, Unique, Xiromed, and Zydus Lifesciences, and is included in thirteen NDAs. It is available from thirty 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. Thirty-two suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.

Summary for 076449

Tradename:	MIDODRINE HYDROCHLORIDE
Applicant:	Impax Pharms
Ingredient:	midodrine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 076449

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	May 27, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 27, 2004	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 16, 2005	TE:	AB	RLD:	No

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