Is Aminocaproic acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Aminocaproic acid, including Amiroic (0.25 g/ml, Oral solution, SAR 3943.25).

Is Aminocaproic acid approved by the US FDA?

Drugs@FDA lists 31 application product lines for Aminocaproic acid, including AMICAR (Prescription); AMICAR (Prescription); AMINOCAPROIC ACID IN PLASTIC CONTAINER (Prescription); AMINOCAPROIC ACID (Prescription); AMINOCAPROIC ACID (Prescription).

Active substance

Aminocaproic acid

SFDA 3
US FDA 31
US price lines 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Amiroic	0.25 g/ml	Oral solution · Oral use	1 Bottle	SAR 3943.25	Generic · Prescription	Saudi Amarox	Valid
EPSIKAPRON AMP 4G+WATER FOR INJ 10ML	400 mg/ml	Injection · Intravenous use	10 Ampoule	SAR 69.00	NCE · Prescription	OCTAPHARMA	Withdrawn by MAH · Not Marketed
EPSIKAPRON EFF. POWDER 9 GM	9 g	Oral powder · Oral use	30 Sachet	SAR 33.50	NCE · Prescription	OCTAPHARMA	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
AMICAR	500MG; 1GM	tablet · oral	HIKMA PHARMS	Prescription	3 Jun 1964
AMICAR	0.25GM/ML	solution · oral	HIKMA PHARMS	Prescription	4 Jun 1964
AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	injectable · injection	HOSPIRA	Prescription	9 Mar 1987
AMINOCAPROIC ACID	250MG/ML	injectable · injection	LUITPOLD	Prescription	1 Dec 1987
AMINOCAPROIC ACID	500MG; 1GM	tablet · oral	SUNNY	Prescription	27 Nov 2018
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	AMNEAL	Prescription	23 Aug 2019
AMINOCAPROIC ACID	500MG	tablet · oral	AMNEAL	Prescription	26 Nov 2019
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	TP ANDA HOLDINGS	Prescription	11 Aug 2020
AMINOCAPROIC ACID	500MG; 1GM	tablet · oral	MSN	Prescription	6 Nov 2020
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	CARNEGIE	Prescription	26 Jan 2021
AMINOCAPROIC ACID	500MG; 1GM	tablet · oral	PHARMOBEDIENT	Prescription	12 Feb 2021
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	AJENAT PHARMS	Prescription	8 Apr 2021
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	REGCON HOLDINGS	Prescription	23 Mar 2022
AMINOCAPROIC ACID	500MG; 1GM	tablet · oral	RISING	Prescription	14 Sep 2022
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	AUROBINDO PHARMA	Prescription	26 Sep 2022
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	ANNORA PHARMA	Prescription	4 Nov 2022
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	SUNNY	Prescription	27 Dec 2023
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	MSN	Prescription	26 Sep 2024
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	APOZEAL PHARMS	Prescription	19 May 2025
AMINOCAPROIC ACID	250MG/ML	injectable · injection	ZENARA	Prescription	28 Aug 2025
AMICAR	250MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	EPIC PHARMA LLC	Discontinued	8 Jun 1964
AMINOCAPROIC ACID	250MG/ML	injectable · injection	BAXTER HLTHCARE	Discontinued	29 Oct 1982
AMINOCAPROIC ACID	250MG/ML	injectable · injection	ABRAXIS PHARM	Discontinued	17 Jun 1986
AMINOCAPROIC ACID	250MG/ML	injectable · injection	HOSPIRA	Discontinued	16 Jun 1988
AMINOCAPROIC ACID	0.25GM/ML	solution · oral	EPIC PHARMA LLC	Discontinued	2 Sep 1998

6 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMINOCAPROIC ACID 0.25 GRAM/ML	$0.57363	per ML	23 Sep 2026
US NADAC	AMINOCAPROIC ACID 1,000 MG TAB	$8.31219	per EA	23 Sep 2026
US NADAC	AMINOCAPROIC ACID 500 MG TAB	$2.52362	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.