Application Sponsors
| ANDA 087711 | WATSON LABS TEVA | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 16MG BASE/ML | 0 | DEXAMETHASONE ACETATE | DEXAMETHASONE ACETATE |
FDA Submissions
| ORIG | 1 | AP | 1982-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1983-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1984-12-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-06-16 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1988-12-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-03-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-03-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1991-03-21 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1992-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1989-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1989-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1991-01-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1992-05-11 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1994-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1993-12-20 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1994-11-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1996-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1998-05-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1999-02-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1999-02-19 | |
| LABELING; Labeling | SUPPL | 28 | AP | 2014-12-02 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 7 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 87711
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"DEXAMETHASONE ACETATE","activeIngredients":"DEXAMETHASONE ACETATE","strength":"EQ 16MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DEXAMETHASONE ACETATE","submission":"DEXAMETHASONE ACETATE","actionType":"EQ 16MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)