Aminocaproic Acid

Sold as Amicar, Aminocaproic Acid. Every FDA application for this active ingredient: 4 branded and 27 generic.

As of Nov 15, 2026, FDA lists 31 applications for Aminocaproic Acid (sold as Amicar, Aminocaproic Acid), first approved Jun 3, 1964, with 1 new use approved and 0 published complete response letters.

First approved: Jun 3, 1964
Applications: 31
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $1.8M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Aminocaproic Acid	Part D	$1.8M	-17%	1,144

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

AMINOCAPROIC ACID 0.25 GRAM/ML: $0.581 per MLGeneric · -38% in a year
AMINOCAPROIC ACID 1,000 MG TAB: $8.30 per unitGeneric · +1% in a year
AMINOCAPROIC ACID 500 MG TAB: $2.48 per unitGeneric · -30% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

For the topical treatment of traumatic hyphema of the eye.Eastern Virginia Medical School · designated Jan 6, 1995

Clinical Trials

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


Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated CoagulationPostoperative Pain · NYU Langone Health	Phase 4	Not yet recruiting	Jun 12, 2026
Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac SurgeryThoracic Surgery, Heart Diseases · Saint Petersburg State University, Russia	Not applicable	Recruiting	Jul 9, 2024
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension · Duke University	—	Recruiting	Feb 20, 2020
Efficacy of Amicar for Children Having Craniofacial SurgeryCraniosynostosis · Children's National Research Institute	Phase 2	Active, not recruiting	Sep 3, 2014

Applications

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


Jun 3, 1964	AmicarNDA 15197 · New molecular entity	Hikma	21	Marketed
Jun 4, 1964	AmicarNDA 15230 · New dosage form	Hikma	19	Marketed
Jun 8, 1964	AmicarNDA 15229 · New dosage form	Epic Pharma LLC	19	Discontinued
Oct 29, 1982	Aminocaproic AcidNDA 18590	Baxter Hlthcare	7	Discontinued
Jun 17, 1986	Aminocaproic AcidANDA 70522	Abraxis Pharm	0	Discontinued
Mar 9, 1987	Aminocaproic Acid In Plastic ContainerANDA 70010	Hospira	13	Marketed
Dec 1, 1987	Aminocaproic AcidANDA 71192	Luitpold	8	Marketed
Jun 16, 1988	Aminocaproic AcidANDA 70888	Hospira	7	Discontinued
Sep 2, 1998	Aminocaproic AcidANDA 74759	Epic Pharma LLC	5	Discontinued
May 24, 2001	AminocaproicANDA 75602	Hikma	4	Discontinued
Nov 27, 2018	Aminocaproic AcidANDA 209060	Sunny	0	Marketed
Aug 23, 2019	Aminocaproic AcidANDA 212780	Amneal	0	Marketed
Nov 26, 2019	Aminocaproic AcidANDA 212492	Amneal	0	Marketed
Feb 26, 2020	Aminocaproic AcidANDA 212814	Vistapharm LLC	0	Discontinued
Aug 11, 2020	Aminocaproic AcidANDA 212494	Tp Anda Holdings	0	Marketed
Nov 6, 2020	Aminocaproic AcidANDA 212938	Msn	0	Marketed
Dec 14, 2020	Aminocaproic AcidANDA 211629	Ani Pharms	0	Discontinued
Jan 26, 2021	Aminocaproic AcidANDA 214140	Carnegie	0	Marketed
Feb 12, 2021	Aminocaproic AcidANDA 213928	Pharmobedient	0	Marketed
Apr 8, 2021	Aminocaproic AcidANDA 213825	Ajenat Pharms	0	Marketed
Jun 14, 2021	Aminocaproic AcidANDA 212110	Adaptis	0	Discontinued
Mar 23, 2022	Aminocaproic AcidANDA 215510	Regcon Holdings	0	Marketed
Sep 14, 2022	Aminocaproic AcidANDA 213944	Rising	0	Marketed
Sep 26, 2022	Aminocaproic AcidANDA 216804	Aurobindo Pharma	0	Marketed
Nov 4, 2022	Aminocaproic AcidANDA 216464	Annora Pharma	0	Marketed
Mar 24, 2023	Aminocaproic AcidANDA 214458	Taro	0	Discontinued
Dec 27, 2023	Aminocaproic AcidANDA 213213	Sunny	0	Marketed
Sep 26, 2024	Aminocaproic AcidANDA 215100	Msn	0	Marketed
May 19, 2025	Aminocaproic AcidANDA 213216	Pharmazone	0	Marketed
Aug 28, 2025	Aminocaproic AcidANDA 215374	Zenara	0	Marketed
—	Aminocaproic AcidANDA 70694	Quad Pharms	0	Discontinued

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