NDA 021241

JANSSEN PHARMS

FDA Drug Application

Application #021241

Documents

• Label: 2002-08-22
• Label: 2015-08-04
• Letter: 2002-08-22
• Letter: 2012-06-20
• Letter: 2015-08-03
• Label: 2012-07-13
• Review: 2004-08-26
• Review: 2006-07-11
• Label: 2017-08-09
• Letter: 2017-08-15

Application Sponsors

NDA 021241

JANSSEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

1

ORTHO TRI-CYCLEN LO

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2003-01-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2012-06-18	STANDARD
LABELING; Labeling	SUPPL	25	AP	2015-07-31	STANDARD
LABELING; Labeling	SUPPL	27	AP	2017-08-09	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	17	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	6

TE Codes

001

Prescription

AB

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21241
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO TRI-CYCLEN LO","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021241s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2015","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021241s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021241s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21241lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ORTHO TRI-CYCLEN LO","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)