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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 two suppliers. Additional details are available on the AMICAR profile page.

The generic ingredient in AMICAR is aminocaproic acid. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

Summary for NDA: 015197

Clover Pharms
aminocaproic acid
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders

Pharmacology for NDA: 015197

Physiological EffectDecreased Fibrinolysis

Suppliers and Packaging for NDA: 015197

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
aminocaproic acid
TABLET;ORAL 015197 NDA Clover Pharmaceuticals Corp. 49411-050 49411-050-30 30 TABLET in 1 BOTTLE, PLASTIC (49411-050-30)
aminocaproic acid
TABLET;ORAL 015197 NDA Clover Pharmaceuticals Corp. 49411-051 49411-051-30 30 TABLET in 1 BOTTLE, PLASTIC (49411-051-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

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

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