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Generated: November 22, 2018

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Details for New Drug Application (NDA): 019281

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NDA 019281 describes CYKLOKAPRON, which is a drug marketed by Pharmacia And Upjohn and is included in two NDAs. It is available from one supplier. Additional details are available on the CYKLOKAPRON profile page.

The generic ingredient in CYKLOKAPRON is tranexamic acid. There are eight drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 019281
Tradename:CYKLOKAPRON
Applicant:Pharmacia And Upjohn
Ingredient:tranexamic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019281
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 019281
Suppliers and Packaging for NDA: 019281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYKLOKAPRON tranexamic acid INJECTABLE;INJECTION 019281 NDA Pharmacia and Upjohn Company LLC 0013-1114 0013-1114-10 10 CARTON in 1 BOX (0013-1114-10) > 1 AMPULE in 1 CARTON > 10 mL in 1 AMPULE (0013-1114-01)
CYKLOKAPRON tranexamic acid INJECTABLE;INJECTION 019281 NDA Pharmacia and Upjohn Company LLC 0013-1114 0013-1114-15 1 AMPULE in 1 CARTON (0013-1114-15) > 10 mL in 1 AMPULE (0013-1114-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Dec 30, 1986TE:APRLD:Yes

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