Documents
Application Sponsors
Marketing Status
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
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
)
)