Application Sponsors
| ANDA 087795 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
| 001 | CREAM;TOPICAL | 1% | 0 | HYDROCORTISONE | HYDROCORTISONE |
FDA Submissions
| ORIG | 1 | AP | 1983-05-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-06-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-06-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-07-26 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1991-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1996-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1996-06-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-12-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2001-04-26 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | 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 | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 87795
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)