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Generated: April 19, 2019

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Details for New Drug Application (NDA): 015230

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NDA 015230 describes AMICAR, which is a drug marketed by Clover Pharms and is included in three NDAs. It is available from four 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. Eight suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
Summary for 015230
Applicant:Clover Pharms
Ingredient:aminocaproic acid
Formulation / Manufacturing:see details
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 SYRUP;ORAL 015230 NDA AUTHORIZED GENERIC Akorn Inc. 17478-447 17478-447-08 236.5 mL in 1 BOTTLE, PLASTIC (17478-447-08)
AMICAR aminocaproic acid SYRUP;ORAL 015230 NDA Clover Pharmaceuticals Corp. 49411-052 49411-052-08 236.5 mL in 1 BOTTLE, PLASTIC (49411-052-08)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength1.25GM/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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