Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL-21 | 0.15MG;0.03MG | 0 | ORTHO-CEPT | DESOGESTREL; ETHINYL ESTRADIOL |
002 | TABLET;ORAL-28 | 0.15MG;0.03MG | 0 | ORTHO-CEPT | DESOGESTREL; ETHINYL ESTRADIOL |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1992-12-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-01-05 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-11-04 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1995-06-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-12-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-02-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-03-04 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 1996-02-14 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 1997-02-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-11-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-11-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-03-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2001-06-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-06-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2013-10-03 | STANDARD |
LABELING; Labeling | SUPPL | 27 | AP | 2012-06-18 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2013-10-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2014-04-08 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2015-12-01 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2017-08-09 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 25 | Null | 6 |
SUPPL | 27 | Null | 15 |
SUPPL | 28 | Null | 15 |
SUPPL | 30 | Null | 15 |
SUPPL | 33 | Null | 0 |
SUPPL | 34 | Null | 15 |
SUPPL | 36 | Null | 15 |
SUPPL | 37 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20301
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ORTHO-CEPT","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORTHO-CEPT","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020301s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2015","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020301s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020301Orig1s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020301s027lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ORTHO-CEPT","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ORTHO-CEPT","submission":"DESOGESTREL; ETHINYL ESTRADIOL","actionType":"0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-08-09
)
)