Last Updated: September 25, 2026

Details for New Drug Application (NDA): 211629

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NDA 211629 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Zenara, Ajenat Pharms, Amneal, Annora Pharma, Apozeal Pharms, Aurobindo Pharma, Carnegie, Epic Pharma Llc, MSN, Regcon Holdings, Sunny, Taro, Tp Anda Holdings, Vistapharm Llc, Adaptis, Ani Pharms, and Rising, and is included in twenty-six NDAs. It is available from nineteen suppliers. Additional details are available on the AMINOCAPROIC ACID profile page.

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

Summary for 211629

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

Medical Subject Heading (MeSH) Categories for 211629

Antifibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Dec 14, 2020	TE:		RLD:	No

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