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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 213944

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NDA 213944 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Gen Ilac, Hospira, Luitpold, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Epic Pharma Llc, MSN, Pharmobedient, 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 seventeen 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 suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for 213944

Tradename:	AMINOCAPROIC ACID
Applicant:	Somerset Theraps Llc
Ingredient:	aminocaproic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 213944

Antifibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Sep 14, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Sep 14, 2022	TE:	AB	RLD:	No

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