Application Sponsors
| ANDA 089682 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
| 001 | CREAM;TOPICAL | 2.5% | 0 | HYDROCORTISONE | HYDROCORTISONE |
FDA Submissions
| ORIG | 1 | AP | 1988-03-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-11-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-11-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-09-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-09-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-09-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-09-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-11-20 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1998-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-12-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-07-11 | |
| LABELING; Labeling | SUPPL | 17 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-12-13 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| 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 | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 89682
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"2.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"2.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)