Last Updated: June 25, 2026

Details for New Drug Application (NDA): 213825

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NDA 213825 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Zenara, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Carnegie, Epic Pharma Llc, MSN, Regcon Holdings, Sciegen Pharms, Sunny, Taro, Tp Anda Holdings, Vistapharm Llc, Adaptis, Ani Pharms, and Somerset Theraps Llc, and is included in twenty-six NDAs. It is available from eighteen suppliers. Additional details are available on the AMINOCAPROIC ACID profile page.

The generic ingredient in AMINOCAPROIC ACID is aminocaproic acid. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for 213825

Tradename:	AMINOCAPROIC ACID
Applicant:	Ajenat Pharms
Ingredient:	aminocaproic acid
Patents:	0

Pharmacology for NDA: 213825

Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 213825

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 213825

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	213825	ANDA	BPI LABS LLC	54288-151	54288-151-01	236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.25GM/ML
Approval Date:	Apr 8, 2021	TE:	AA	RLD:	No

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