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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 216804

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NDA 216804 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 216804

Tradename:	AMINOCAPROIC ACID
Applicant:	Aurobindo Pharma
Ingredient:	aminocaproic acid
Patents:	0

Pharmacology for NDA: 216804

Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 216804

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 216804

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	216804	ANDA	Aurobindo Pharma Limited	59651-573	59651-573-08	236.5 mL in 1 BOTTLE (59651-573-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.25GM/ML
Approval Date:	Sep 26, 2022	TE:	AA	RLD:	No

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