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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 015230


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NDA 015230 describes AMICAR, which is a drug marketed by Epic Pharma Llc and Hikma and is included in three NDAs. It is available from two suppliers. 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-one suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
Summary for 015230
Tradename:AMICAR
Applicant:Hikma
Ingredient:aminocaproic acid
Patents:0
Pharmacology for NDA: 015230
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 015230
Suppliers and Packaging for NDA: 015230
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMICAR aminocaproic acid SOLUTION;ORAL 015230 NDA AUTHORIZED GENERIC Hikma Pharmaceuticals USA Inc. 0054-1100 0054-1100-58 236.5 mL in 1 BOTTLE, PLASTIC (0054-1100-58)
AMICAR aminocaproic acid SOLUTION;ORAL 015230 NDA AUTHORIZED GENERIC Akorn Operating Company LLC 17478-447 17478-447-08 236.5 mL in 1 BOTTLE, PLASTIC (17478-447-08)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength0.25GM/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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