Details for New Drug Application (NDA): 209060

NDA 209060 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Amneal, Annora Pharma, Aurobindo Pharma, Belcher, Carnegie, Epic Pharma Llc, Florida, MSN, Sunny, Taro, Trupharma, Vistapharm Llc, Adaptis, Ani Pharms, and Appco, and is included in twenty-four 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-one suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for 209060

Tradename:	AMINOCAPROIC ACID
Applicant:	Sunny
Ingredient:	aminocaproic acid
Patents:	0

Pharmacology for NDA: 209060

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 209060

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 209060

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	209060	ANDA	American Health Packaging	60687-739	60687-739-25	30 BLISTER PACK in 1 CARTON (60687-739-25) / 1 TABLET in 1 BLISTER PACK (60687-739-95)
AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	209060	ANDA	Vitruvias Therapeutics	69680-115	69680-115-00	100 TABLET in 1 BOTTLE (69680-115-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 27, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Nov 27, 2018	TE:	AB	RLD:	No

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