Application Sponsors
| ANDA 086155 | TARO PHARM INDS LTD | |
Marketing Status
Application Products
| 001 | CREAM;TOPICAL | 1% | 0 | HYDROCORTISONE | HYDROCORTISONE |
FDA Submissions
| ORIG | 1 | AP | 1978-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1982-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-06-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1982-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1983-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1984-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1985-11-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1986-01-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1987-01-08 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1989-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1989-07-31 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1989-11-13 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1989-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1991-01-03 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1991-01-23 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1992-11-16 | |
| LABELING; Labeling | SUPPL | 35 | AP | 1992-11-23 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1993-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2001-06-20 | |
| LABELING; Labeling | SUPPL | 42 | AP | 2005-04-28 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 39 | Null | 0 |
CDER Filings
TARO PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 86155
[companyName] => TARO PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)