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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 seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for NDA: 019281

Pharmacia And Upjohn
tranexamic acid
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders

Pharmacology for NDA: 019281

Physiological EffectDecreased Fibrinolysis

Suppliers and Packaging for NDA: 019281

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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 (0013-1114-01) > 10 mL in 1 AMPULE
tranexamic acid
INJECTABLE;INJECTION 019281 NDA Pharmacia and Upjohn Company LLC 0013-1114 0013-1114-21 10 CARTON in 1 BOX (0013-1114-21) > 1 VIAL in 1 CARTON (0013-1114-20) > 10 mL in 1 VIAL

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019281

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
tranexamic acid
INJECTABLE;INJECTION019281-001Dec 30, 19863,950,405► subscribe
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