Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL-21 | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | 0 | ORTHO-NOVUM 7/7/7-21 | ETHINYL ESTRADIOL; NORETHINDRONE |
002 | TABLET;ORAL-28 | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | 1 | ORTHO-NOVUM 7/7/7-28 | ETHINYL ESTRADIOL; NORETHINDRONE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1984-04-04 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 1985-04-05 | |
LABELING; Labeling | SUPPL | 3 | AP | 1985-10-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-11-23 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 1987-02-02 | |
LABELING; Labeling | SUPPL | 7 | AP | 1988-09-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-06-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-10-28 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 1989-07-19 | |
LABELING; Labeling | SUPPL | 11 | AP | 1989-10-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1990-01-18 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 1991-09-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1991-03-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1994-03-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1993-05-18 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 1994-01-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1993-11-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-02-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1995-09-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1995-11-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-05-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-04-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1997-01-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1997-02-24 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 1999-08-27 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 1999-08-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1998-04-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1998-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 1999-08-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2000-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2000-06-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2001-07-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2002-02-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2002-06-03 | STANDARD |
LABELING; Labeling | SUPPL | 50 | AP | 2013-10-03 | STANDARD |
LABELING; Labeling | SUPPL | 53 | AP | 2012-06-18 | STANDARD |
LABELING; Labeling | SUPPL | 54 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2013-10-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 2014-09-11 | STANDARD |
LABELING; Labeling | SUPPL | 63 | AP | 2015-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 64 | AP | 2017-08-09 | STANDARD |
Submissions Property Types
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 34 | Null | 0 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 0 |
SUPPL | 39 | Null | 0 |
SUPPL | 50 | Null | 7 |
SUPPL | 53 | Null | 6 |
SUPPL | 54 | Null | 7 |
SUPPL | 56 | Null | 7 |
SUPPL | 60 | Null | 7 |
SUPPL | 62 | Null | 0 |
SUPPL | 63 | Null | 15 |
SUPPL | 64 | Null | 6 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 18985
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ORTHO-NOVUM 7\/7\/7-21","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORTHO-NOVUM 7\/7\/7-28","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017735s118,017919s100,018985s064lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/017735s117,017919s099,018985s063lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2013","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2012","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017735s107lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ORTHO-NOVUM 7\/7\/7-21","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","submissionClassification":"TABLET;ORAL-21","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORTHO-NOVUM 7\/7\/7-28","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-08-09
)
)