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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 075602

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NDA 075602 describes AMINOCAPROIC, which is a drug marketed by Hikma, 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-seven NDAs. Additional details are available on the AMINOCAPROIC profile page.

The generic ingredient in AMINOCAPROIC 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 075602

Tradename:	AMINOCAPROIC
Applicant:	Hikma
Ingredient:	aminocaproic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 075602

Antifibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 24, 2001	TE:		RLD:	No

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