Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL-28 | 0.35MG | 1 | MICRONOR | NORETHINDRONE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1973-01-02 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 1975-03-06 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 1975-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1975-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1975-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1975-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1975-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1975-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1975-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1975-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1975-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1975-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1976-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1976-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1976-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1978-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1978-05-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1978-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1978-09-25 | STANDARD |
| REMS; REMS | SUPPL | 39 | AP | 1979-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 1978-12-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1979-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 1979-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1979-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1980-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1980-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1980-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 1982-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1983-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 1983-06-15 | |
| LABELING; Labeling | SUPPL | 60 | AP | 1983-09-29 | |
| LABELING; Labeling | SUPPL | 61 | AP | 1984-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1984-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 1985-04-05 | |
| LABELING; Labeling | SUPPL | 65 | AP | 1985-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1987-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 68 | AP | 1987-02-26 | |
| LABELING; Labeling | SUPPL | 69 | AP | 1988-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1988-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 1989-07-19 | |
| LABELING; Labeling | SUPPL | 72 | AP | 1989-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 1990-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 1991-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1990-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1993-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1993-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 1994-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 1995-09-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 81 | AP | 1995-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 82 | AP | 1996-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 83 | AP | 1996-03-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 84 | AP | 1997-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 85 | AP | 1999-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 86 | AP | 1998-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 87 | AP | 1998-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 88 | AP | 2000-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 89 | AP | 2000-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 90 | AP | 2000-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 91 | AP | 2002-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 92 | AP | 2003-10-01 | STANDARD |
| LABELING; Labeling | SUPPL | 100 | AP | 2021-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 101 | AP | 2008-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 106 | AP | 2014-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 107 | AP | 2014-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 108 | AP | 2021-11-15 | STANDARD |
Submissions Property Types
| 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 | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 80 | Null | 0 |
| SUPPL | 81 | Null | 0 |
| SUPPL | 82 | Null | 0 |
| SUPPL | 84 | Null | 0 |
| SUPPL | 86 | Null | 0 |
| SUPPL | 87 | Null | 0 |
| SUPPL | 88 | Null | 0 |
| SUPPL | 89 | Null | 0 |
| SUPPL | 90 | Null | 0 |
| SUPPL | 91 | Null | 0 |
| SUPPL | 100 | Null | 7 |
| SUPPL | 106 | Null | 15 |
| SUPPL | 107 | Null | 0 |
| SUPPL | 108 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 16954
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"MICRONOR","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2021","submission":"SUPPL-108","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/016954s100s108lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2021","submission":"SUPPL-100","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/016954s100s108lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2014","submission":"SUPPL-106","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/016954s106lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2008","submission":"SUPPL-101","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/016954s101lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MICRONOR","submission":"NORETHINDRONE","actionType":"0.35MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-11-15
)
)