Details for New Drug Application (NDA): 212780

NDA 212780 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 fifteen 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 212780

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

Pharmacology for NDA: 212780

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 212780

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 212780

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	212780	ANDA	Amneal Pharmaceuticals NY LLC	69238-1596	69238-1596-4	10 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4) / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3)
AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	212780	ANDA	Amneal Pharmaceuticals NY LLC	69238-1596	69238-1596-8	236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.25GM/ML
Approval Date:	Aug 23, 2019	TE:	AA	RLD:	No

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