Details for New Drug Application (NDA): 071192

NDA 071192 describes AMINOCAPROIC ACID, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Zenara, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Carnegie, Epic Pharma Llc, MSN, 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 eighteen 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 071192

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

Pharmacology for NDA: 071192

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 071192

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 071192

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	INJECTABLE;INJECTION	071192	ANDA	American Regent, Inc.	0517-9120	0517-9120-25	25 VIAL, MULTI-DOSE in 1 TRAY (0517-9120-25) / 20 mL in 1 VIAL, MULTI-DOSE
AMINOCAPROIC ACID	aminocaproic acid	INJECTABLE;INJECTION	071192	ANDA	American Regent, Inc.	0517-9191	0517-9191-25	25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MG/ML
Approval Date:	Dec 1, 1987	TE:	AP	RLD:	No

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