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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215374

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NDA 215374 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Gen Ilac, Hospira, Luitpold, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Carnegie, Epic Pharma Llc, MSN, Regcon Holdings, Sciegen Pharms Inc, Sunny, Taro, Tp Anda Holdings, Vistapharm Llc, Adaptis, Ani Pharms, Pharmobedient, and Somerset Theraps Llc, and is included in twenty-six NDAs. It is available from sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for 215374

Tradename:	AMINOCAPROIC ACID
Applicant:	Gen Ilac
Ingredient:	aminocaproic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 215374

Antifibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MG/ML
Approval Date:	Aug 28, 2025	TE:	AP	RLD:	No

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