Details for New Drug Application (NDA): 213928

NDA 213928 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 213928

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

Pharmacology for NDA: 213928

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 213928

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 213928

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	213928	ANDA	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-798	24658-798-30	30 TABLET in 1 BOTTLE (24658-798-30)
AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	213928	ANDA	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-799	24658-799-30	30 TABLET in 1 BOTTLE (24658-799-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Feb 12, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Feb 12, 2021	TE:	AB	RLD:	No

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