Documents
Application Sponsors
Marketing Status
Application Products
002 | TABLET;ORAL-28 | 0.035MG;1MG | 1 | ORTHO-NOVUM 1/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1977-06-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1977-10-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-07-31 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1980-07-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1978-05-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1978-04-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1978-02-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1978-02-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1978-02-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1979-06-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-10-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1979-11-08 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 1979-12-05 | |
LABELING; Labeling | SUPPL | 21 | AP | 1979-12-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1980-03-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1980-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1980-11-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1980-11-12 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 1982-09-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1983-06-09 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 1983-06-15 | |
LABELING; Labeling | SUPPL | 34 | AP | 1983-09-29 | |
LABELING; Labeling | SUPPL | 35 | AP | 1984-01-30 | |
LABELING; Labeling | SUPPL | 36 | AP | 1984-06-21 | |
LABELING; Labeling | SUPPL | 37 | AP | 1985-04-05 | |
LABELING; Labeling | SUPPL | 38 | AP | 1985-10-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1987-11-23 | STANDARD |
LABELING; Labeling | SUPPL | 41 | AP | 1987-02-26 | |
LABELING; Labeling | SUPPL | 42 | AP | 1988-09-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1988-06-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1988-10-28 | STANDARD |
LABELING; Labeling | SUPPL | 45 | AP | 1989-07-19 | |
LABELING; Labeling | SUPPL | 46 | AP | 1989-10-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1990-01-18 | STANDARD |
LABELING; Labeling | SUPPL | 49 | AP | 1991-09-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1991-03-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1994-03-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1993-05-18 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 1994-01-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1993-11-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1995-02-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1995-09-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1995-11-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1996-05-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1996-04-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1997-01-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1997-02-24 | STANDARD |
LABELING; Labeling | SUPPL | 65 | AP | 1999-08-27 | STANDARD |
LABELING; Labeling | SUPPL | 66 | AP | 1999-01-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1998-04-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1998-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 69 | AP | 1999-08-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 2000-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 71 | AP | 2000-06-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 2001-07-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 2002-02-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 2002-06-03 | STANDARD |
LABELING; Labeling | SUPPL | 86 | AP | 2013-10-03 | STANDARD |
LABELING; Labeling | SUPPL | 89 | AP | 2012-06-18 | STANDARD |
LABELING; Labeling | SUPPL | 90 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 92 | AP | 2013-10-02 | STANDARD |
LABELING; Labeling | SUPPL | 96 | AP | 2013-10-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 98 | AP | 2014-09-11 | STANDARD |
LABELING; Labeling | SUPPL | 99 | AP | 2015-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 100 | AP | 2017-08-09 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 40 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 44 | Null | 0 |
SUPPL | 48 | Null | 0 |
SUPPL | 50 | Null | 0 |
SUPPL | 52 | Null | 0 |
SUPPL | 55 | Null | 0 |
SUPPL | 57 | Null | 0 |
SUPPL | 58 | Null | 0 |
SUPPL | 59 | Null | 0 |
SUPPL | 60 | Null | 0 |
SUPPL | 61 | Null | 0 |
SUPPL | 62 | Null | 0 |
SUPPL | 63 | Null | 0 |
SUPPL | 64 | Null | 0 |
SUPPL | 67 | Null | 0 |
SUPPL | 68 | Null | 0 |
SUPPL | 70 | Null | 0 |
SUPPL | 73 | Null | 0 |
SUPPL | 74 | Null | 0 |
SUPPL | 75 | Null | 0 |
SUPPL | 86 | Null | 15 |
SUPPL | 89 | Null | 6 |
SUPPL | 90 | Null | 7 |
SUPPL | 92 | Null | 6 |
SUPPL | 96 | Null | 7 |
SUPPL | 98 | Null | 0 |
SUPPL | 99 | Null | 6 |
SUPPL | 100 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 17919
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ORTHO-NOVUM 1\/35-28","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;1MG **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-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017735s118,017919s100,018985s064lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"SUPPL-99","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-86","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-89","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017735s107lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ORTHO-NOVUM 1\/35-28","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG;1MG **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
)
)