Application Sponsors
ANDA 076592 | PERRIGO ISRAEL | |
Marketing Status
Application Products
001 | CREAM, AUGMENTED;TOPICAL | EQ 0.05% BASE | 0 | BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE |
FDA Submissions
| ORIG | 1 | AP | 2003-12-09 | |
LABELING; Labeling | SUPPL | 3 | AP | 2009-09-28 | |
LABELING; Labeling | SUPPL | 5 | AP | 2020-08-25 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-08-25 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 7 |
SUPPL | 5 | Null | 15 |
SUPPL | 7 | Null | 15 |
TE Codes
CDER Filings
PERRIGO ISRAEL
cder:Array
(
[0] => Array
(
[ApplNo] => 76592
[companyName] => PERRIGO ISRAEL
[docInserts] => ["",""]
[products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"CREAM, AUGMENTED;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BETAMETHASONE DIPROPIONATE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"CREAM, AUGMENTED;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)