NDA 019280

PHARMACIA AND UPJOHN

FDA Drug Application

Application #019280

Documents

• Letter: 1999-09-09
• Review: 1999-09-09
• Review: 2019-02-15

Application Sponsors

NDA 019280

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

CYKLOKAPRON

TRANEXAMIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1986-12-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	14
SUPPL	8	Null	14

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19280
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYKLOKAPRON","activeIngredients":"TRANEXAMIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYKLOKAPRON","submission":"TRANEXAMIC ACID","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)