Details for New Drug Application (NDA): 212492

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NDA 212492 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, Pharmazone, Regcon Holdings, Sunny, Taro, Tp Anda Holdings, Vistapharm Llc, Adaptis, Ani Pharms, Pharmobedient, and Rising, and is included in twenty-six NDAs. It is available from twenty-one 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-four suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for 212492

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

Pharmacology for NDA: 212492

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 212492

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 212492

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	212492	ANDA	Major Pharmaceuticals	0904-7165	0904-7165-07	30 BLISTER PACK in 1 CARTON (0904-7165-07) / 1 TABLET in 1 BLISTER PACK
AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	212492	ANDA	Amneal Pharmaceuticals LLC	69238-1637	69238-1637-3	30 TABLET in 1 BOTTLE, PLASTIC (69238-1637-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 26, 2019	TE:	AB	RLD:	No

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