Midodrine Hydrochloride

Sold as Proamatine. Every FDA application for this active ingredient: 1 branded and 14 generic.

As of Nov 15, 2026, FDA lists 15 applications for Midodrine Hydrochloride (sold as Proamatine), first approved Sep 6, 1996, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 6, 1996
Applications: 15
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $104M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Midodrine HCl	Part D	$104M	+1%	494,328

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

MIDODRINE HCL 10 MG TABLET: $0.146 per unitGeneric · -3% in a year
MIDODRINE HCL 2.5 MG TABLET: $0.077 per unitGeneric · +9% in a year
MIDODRINE HCL 5 MG TABLET: $0.107 per unitGeneric · -5% in a year

Clinical Trials

11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis.Liver Cirrhosis · Institute of Liver and Biliary Sciences, India	Not applicable	Not yet recruiting	Mar 12, 2026
Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure.Acute on Chronic Liver Failure · Institute of Liver and Biliary Sciences, India	Not applicable	Not yet recruiting	Feb 20, 2026
Midodrine in Heart Failure With Reduced Ejection Fraction With HypotensionHeart Failure With Reduced Ejection Fraction, Hypotension · Ottawa Heart Institute Research Corporation	Phase 2 / Phase 3	Recruiting	May 8, 2024
MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) TrialSepsis, Low Blood Pressure · Mayo Clinic	Phase 2	Recruiting	Mar 20, 2024
Treatment of Orthostatic Hypotension in SCIHypotension · James J. Peters Veterans Affairs Medical Center	Phase 4	Recruiting	May 3, 2023
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory AscitesCirrhosis, Liver, Acute-On-Chronic Liver Failure · Post Graduate Institute of Medical Education and Research, Chandigarh	—	Active, not recruiting	Jan 26, 2023
Paediatric Syncope in the Emergency DepartmentSyncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome · Dr. Victoria Claydon	Not applicable	Recruiting	Sep 27, 2022
Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)Vasoplegia · University of Alberta	Phase 4	Recruiting	Sep 28, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 6, 1996	ProamatineNDA 19815 · New molecular entity	Takeda Pharms USA	8	Discontinued
Sep 10, 2003	Midodrine HydrochlorideANDA 76577	Mylan Pharms Inc	2	Marketed
Sep 11, 2003	Midodrine HydrochlorideANDA 76514	Chartwell Rx	4	Discontinued
May 27, 2004	Midodrine HydrochlorideANDA 76449	Impax Pharms	2	Discontinued
Nov 3, 2004	OrvatenANDA 76725	Beijing Yiling	2	Marketed
Sep 12, 2006	Midodrine HydrochlorideANDA 77746	Apotex	1	Marketed
Oct 29, 2018	Midodrine HydrochlorideANDA 207169	Ph Health	0	Marketed
Nov 2, 2018	Midodrine HydrochlorideANDA 207613	Unique	0	Marketed
Aug 19, 2019	Midodrine HydrochlorideANDA 212543	Rubicon Research	1	Marketed
Aug 10, 2020	Midodrine HydrochlorideANDA 212774	Aurobindo Pharma Ltd	0	Marketed
Sep 1, 2020	Midodrine HydrochlorideANDA 213055	Zydus Lifesciences	0	Marketed
Oct 1, 2020	Midodrine HydrochlorideANDA 207849	Xiromed	0	Marketed
Jan 21, 2021	Midodrine HydrochlorideANDA 214734	Alembic	0	Marketed
Oct 17, 2023	Midodrine HydrochlorideANDA 211973	Novugen	0	Marketed
Nov 1, 2023	Midodrine HydrochlorideANDA 217271	Mankind Pharma	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA