Application Sponsors
ANDA 070687 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL-28 | 0.035MG;1MG | 0 | NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE |
FDA Submissions
| ORIG | 1 | AP | 1987-01-29 | |
LABELING; Labeling | SUPPL | 3 | AP | 1987-09-28 | |
LABELING; Labeling | SUPPL | 4 | AP | 1987-11-19 | |
LABELING; Labeling | SUPPL | 5 | AP | 1989-07-28 | |
LABELING; Labeling | SUPPL | 6 | AP | 1990-03-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-08-10 | |
LABELING; Labeling | SUPPL | 8 | AP | 1993-11-04 | |
LABELING; Labeling | SUPPL | 9 | AP | 1997-05-01 | |
LABELING; Labeling | SUPPL | 10 | AP | 1997-11-17 | |
LABELING; Labeling | SUPPL | 11 | AP | 2002-05-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-08-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-10-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-05-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-06-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-12-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-12-13 | |
LABELING; Labeling | SUPPL | 43 | AP | 2022-02-24 | STANDARD |
LABELING; Labeling | SUPPL | 44 | AP | 2022-04-29 | STANDARD |
Submissions Property Types
SUPPL | 7 | 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 | 43 | Null | 15 |
SUPPL | 44 | Null | 15 |
TE Codes
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 70687
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NORETHINDRONE AND ETHINYL ESTRADIOL","submission":"ETHINYL ESTRADIOL; NORETHINDRONE","actionType":"0.035MG;1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)