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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

Last Updated: March 26, 2023

Details for New Drug Application (NDA): 015197

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NDA 015197 describes AMICAR, which is a drug marketed by Akorn and is included in three NDAs. It is available from one supplier. Additional details are available on the AMICAR profile page.

The generic ingredient in AMICAR 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 015197
Ingredient:aminocaproic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 015197
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 015197
Suppliers and Packaging for NDA: 015197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMICAR aminocaproic acid TABLET;ORAL 015197 NDA AUTHORIZED GENERIC Akorn Operating Company LLC 17478-768 17478-768-30 30 TABLET in 1 BOTTLE (17478-768-30)
AMICAR aminocaproic acid TABLET;ORAL 015197 NDA AUTHORIZED GENERIC Akorn Operating Company LLC 17478-769 17478-769-30 30 TABLET in 1 BOTTLE (17478-769-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Jun 24, 2004TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim

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