Details for New Drug Application (NDA): 019281

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NDA 019281 describes CYKLOKAPRON, which is a drug marketed by Pfizer and 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. Thirty suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for 019281

Tradename:	CYKLOKAPRON
Applicant:	Pfizer
Ingredient:	tranexamic acid
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019281

Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 019281

Antifibrinolytic Agents

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	Pfizer Laboratories Div Pfizer Inc	0013-1114	0013-1114-15	1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01)
CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281	NDA	Pfizer Laboratories Div Pfizer Inc	0013-1114	0013-1114-21	10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Dec 30, 1986	TE:	AP	RLD:	Yes

Expired US Patents for NDA 019281

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281-001	Dec 30, 1986	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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