Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL-21 | 0.035MG;0.25MG | 0 | ORTHO CYCLEN-21 | ETHINYL ESTRADIOL; NORGESTIMATE |
002 | TABLET;ORAL-28 | 0.035MG;0.25MG | 1 | ORTHO CYCLEN-28 | ETHINYL ESTRADIOL; NORGESTIMATE |
FDA Submissions
TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 1989-12-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-05-23 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1991-09-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-06-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1992-10-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-02-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-11-04 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 1994-06-28 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 1996-01-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-11-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-02-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1996-08-02 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 1998-04-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1996-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1999-10-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1999-11-02 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 1999-11-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-09-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2000-06-05 | STANDARD |
LABELING; Labeling | SUPPL | 27 | AP | 2001-01-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2001-07-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2002-01-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2002-06-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2002-09-06 | STANDARD |
S; Supplement | SUPPL | 35 | AP | 2003-01-03 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2007-05-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2008-05-30 | N/A |
LABELING; Labeling | SUPPL | 46 | AP | 2013-10-03 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2012-06-18 | STANDARD |
LABELING; Labeling | SUPPL | 49 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 51 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 54 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2015-05-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2016-06-22 | STANDARD |
LABELING; Labeling | SUPPL | 58 | AP | 2017-08-09 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 33 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 45 | Null | 4 |
SUPPL | 46 | Null | 6 |
SUPPL | 48 | Null | 15 |
SUPPL | 49 | Null | 6 |
SUPPL | 51 | Null | 15 |
SUPPL | 54 | Null | 7 |
SUPPL | 56 | Null | 7 |
SUPPL | 57 | Null | 0 |
SUPPL | 58 | Null | 15 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 19653
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ORTHO CYCLEN-21","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORTHO CYCLEN-28","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG **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-58","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-56","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-46","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-48","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-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019653s037,019697s034lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ORTHO CYCLEN-21","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORTHO CYCLEN-28","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG;0.25MG **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
)
)