NDA 019281

PHARMACIA AND UPJOHN

FDA Drug Application

Application #019281

Documents

• Letter: 1999-09-09
• Letter: 2001-03-27
• Letter: 2013-05-14
• Label: 2013-05-14
• Letter: 2008-12-24
• Letter: 2009-01-30
• Letter: 2011-02-02
• Label: 2009-01-02
• Label: 2011-01-31
• Label: 2015-04-14
• Review: 2001-06-18
• Label: 2017-11-22
• Letter: 2017-11-27
• Label: 2020-06-08
• Letter: 2020-06-08
• Label: 2020-06-16
• Letter: 2021-02-05
• Label: 2021-02-08

Application Sponsors

NDA 019281

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

1

CYKLOKAPRON

TRANEXAMIC ACID

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1986-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-07-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	1999-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-07-31	STANDARD
LABELING; Labeling	SUPPL	13	AP	2001-03-27	STANDARD
LABELING; Labeling	SUPPL	15	AP	2001-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-05-15	STANDARD
LABELING; Labeling	SUPPL	25	AP	2008-12-22	STANDARD
LABELING; Labeling	SUPPL	27	AP	2009-01-28	STANDARD
LABELING; Labeling	SUPPL	30	AP	2011-01-25	STANDARD
LABELING; Labeling	SUPPL	31	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2015-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2015-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2015-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2016-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2016-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2016-08-01	STANDARD
LABELING; Labeling	SUPPL	41	AP	2017-11-21	901 REQUIRED
LABELING; Labeling	SUPPL	44	AP	2020-06-07	STANDARD
LABELING; Labeling	SUPPL	47	AP	2021-02-04	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	16	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	33	Null	14
SUPPL	34	Null	14
SUPPL	35	Null	14
SUPPL	36	Null	14
SUPPL	37	Null	14
SUPPL	40	Null	14
SUPPL	41	Null	7
SUPPL	44	Null	15
SUPPL	47	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

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(
    [0] => Array
        (
            [ApplNo] => 19281
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYKLOKAPRON","activeIngredients":"TRANEXAMIC ACID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/04\/2021","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/019281Orig1s047lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2021","submission":"SUPPL-47","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/019281Orig1s047lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2020","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019281s044lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019281s041lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019281s041lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2014","submission":"SUPPL-33","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019281s033lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/10\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019281s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2011","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019281s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2008","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019281s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CYKLOKAPRON","submission":"TRANEXAMIC ACID","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-02-04
        )

)