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Details for New Drug Application (NDA): 075602

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NDA 075602 describes AMINOCAPROIC, which is a drug marketed by Versapharm Inc, Abraxis Pharm, Hospira, Baxter Hlthcare, and Luitpold, and is included in seven NDAs. It is available from one supplier. Additional details are available on the AMINOCAPROIC profile page.

The generic ingredient in AMINOCAPROIC 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: 075602

Versapharm Inc
aminocaproic acid
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders

Pharmacology for NDA: 075602

Physiological EffectDecreased Fibrinolysis

Suppliers and Packaging for NDA: 075602

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
aminocaproic acid
TABLET;ORAL 075602 ANDA VersaPharm Incorporated 61748-045 61748-045-01 100 TABLET in 1 BOTTLE (61748-045-01)
aminocaproic acid
TABLET;ORAL 075602 ANDA VersaPharm Incorporated 61748-045 61748-045-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE (61748-045-11) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 24, 2001TE:ABRLD:No

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