Application Sponsors
ANDA 074128 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
001 | OINTMENT;TOPICAL | 0.05% | 0 | CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE |
FDA Submissions
| ORIG | 1 | AP | 1994-08-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-12-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-08-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-08-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-08-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-08-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-06-28 | |
LABELING; Labeling | SUPPL | 8 | AP | 1998-01-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-12-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-05-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-05-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-08-29 | |
LABELING; Labeling | SUPPL | 13 | AP | 2002-08-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-05-30 | |
LABELING; Labeling | SUPPL | 16 | AP | 2004-05-18 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
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 | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 74128
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)