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Generated: November 14, 2018

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Details for New Drug Application (NDA): 015197

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

The generic ingredient in AMICAR is aminocaproic acid. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
Summary for 015197
Tradename:AMICAR
Applicant:Clover Pharms
Ingredient:aminocaproic acid
Patents:0
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 Clover Pharmaceuticals Corp. 49411-050 49411-050-30 30 TABLET in 1 BOTTLE, PLASTIC (49411-050-30)
AMICAR aminocaproic acid TABLET;ORAL 015197 NDA Clover Pharmaceuticals Corp. 49411-051 49411-051-30 30 TABLET in 1 BOTTLE, PLASTIC (49411-051-30)

Profile for product number 001

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

Profile for product number 002

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

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