Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL-28 | 0.035MG;0.5MG | 1 | MODICON 28 | ETHINYL ESTRADIOL; NORETHINDRONE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1976-05-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1977-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1977-07-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1978-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1978-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1977-10-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1978-05-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1978-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1978-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1978-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1978-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1979-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1978-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1980-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1979-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 1979-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1979-05-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1979-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1979-11-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1980-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1980-03-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1980-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1980-11-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1980-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1982-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1983-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 1983-06-15 | |
| LABELING; Labeling | SUPPL | 54 | AP | 1983-09-29 | |
| LABELING; Labeling | SUPPL | 55 | AP | 1984-01-30 | |
| LABELING; Labeling | SUPPL | 56 | AP | 1984-06-21 | |
| LABELING; Labeling | SUPPL | 57 | AP | 1985-04-05 | |
| LABELING; Labeling | SUPPL | 58 | AP | 1985-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1987-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 1987-02-26 | |
| LABELING; Labeling | SUPPL | 62 | AP | 1988-09-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1988-06-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1988-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 1989-07-19 | |
| LABELING; Labeling | SUPPL | 66 | AP | 1989-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1990-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 1991-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1991-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 1994-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 1993-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 1994-01-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1993-11-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 1995-02-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1995-09-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1995-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 1996-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 1996-04-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 81 | AP | 1997-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 82 | AP | 1997-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 1999-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 84 | AP | 1999-01-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 85 | AP | 1998-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 86 | AP | 1998-04-28 | STANDARD |
| LABELING; Labeling | SUPPL | 87 | AP | 1999-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 88 | AP | 2000-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 89 | AP | 2000-06-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 91 | AP | 2001-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 92 | AP | 2002-02-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 93 | AP | 2002-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 104 | AP | 2013-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 107 | AP | 2012-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 108 | AP | 2013-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 110 | AP | 2013-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 114 | AP | 2013-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 116 | AP | 2014-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 117 | AP | 2015-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 118 | AP | 2017-08-09 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 0 |
| SUPPL | 80 | Null | 0 |
| SUPPL | 81 | Null | 0 |
| SUPPL | 82 | Null | 0 |
| SUPPL | 85 | Null | 0 |
| SUPPL | 86 | Null | 0 |
| SUPPL | 88 | Null | 0 |
| SUPPL | 91 | Null | 0 |
| SUPPL | 92 | Null | 0 |
| SUPPL | 93 | Null | 0 |
| SUPPL | 104 | Null | 7 |
| SUPPL | 107 | Null | 6 |
| SUPPL | 108 | Null | 7 |
| SUPPL | 110 | Null | 7 |
| SUPPL | 114 | Null | 7 |
| SUPPL | 116 | Null | 0 |
| SUPPL | 117 | Null | 15 |
| SUPPL | 118 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 17735
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"MODICON 28","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;0.5MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-118","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-117","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-104","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-107","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017735s107lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MODICON 28","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG;0.5MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-08-09
)
)