Application Sponsors
| ANDA 074304 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
| 001 | OINTMENT, AUGMENTED;TOPICAL | EQ 0.05% BASE | 0 | BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE |
FDA Submissions
| ORIG | 1 | AP | 1995-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-06-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-07-31 | |
| LABELING; Labeling | SUPPL | 12 | AP | 2002-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-07-31 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2016-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2020-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2020-06-09 | STANDARD |
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 | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 7 |
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 74304
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"OINTMENT, AUGMENTED;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BETAMETHASONE DIPROPIONATE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"OINTMENT, AUGMENTED;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)