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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076514

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NDA 076514 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, Thinq Pharm-cro Pvt, Xiromed, and Zydus Lifesciences, and is included in thirteen NDAs. It is available from thirty-one 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 076514

Tradename:	MIDODRINE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	midodrine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 076514

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 11, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 11, 2003	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jul 2, 2004	TE:		RLD:	No

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