Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL-28 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | 1 | ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE |
| 002 | TABLET;ORAL-21 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | 0 | ORTHO TRI-CYCLEN | ETHINYL ESTRADIOL; NORGESTIMATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1994-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1996-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-02-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1998-04-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1999-11-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2000-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2001-01-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-08-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2001-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2002-01-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2002-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-09-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2003-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2007-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2008-05-30 | N/A |
| LABELING; Labeling | SUPPL | 42 | AP | 2013-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2012-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2013-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2013-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2013-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2015-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2017-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2022-04-29 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 41 | Null | 4 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 44 | Null | 15 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 58 | Null | 7 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 19697
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ORTHO TRI-CYCLEN","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORTHO TRI-CYCLEN","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019653s058,019697s054lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2015","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019653s056,019697s052,021690s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/02\/2013","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019653Orig1s046,019697Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019653s048lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019653s037,019697s034lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ORTHO TRI-CYCLEN","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ORTHO TRI-CYCLEN","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2017-08-09
)
)