Details for New Drug Application (NDA): 215100

NDA 215100 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 Rising, and is included in twenty-six NDAs. It is available from nineteen 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-two suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for 215100

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

Pharmacology for NDA: 215100

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 215100

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 215100

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	215100	ANDA	Novadoz Pharmaceuticals LLC	72205-032	72205-032-71	236.5 mL in 1 BOTTLE, PLASTIC (72205-032-71)
AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	215100	ANDA	Novadoz Pharmaceuticals LLC	72205-032	72205-032-72	473 mL in 1 BOTTLE, PLASTIC (72205-032-72)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.25GM/ML
Approval Date:	Sep 26, 2024	TE:	AA	RLD:	No

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