Application Sponsors
ANDA 076774 | GLAND PHARMA LTD | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 5MG BASE/ML | 0 | HALOPERIDOL | HALOPERIDOL LACTATE |
FDA Submissions
| ORIG | 1 | AP | 2004-08-25 | |
LABELING; Labeling | SUPPL | 4 | AP | 2018-06-08 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2018-06-08 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2018-06-08 | STANDARD |
Submissions Property Types
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 7 | Null | 15 |
TE Codes
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 76774
[companyName] => GLAND PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL LACTATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL LACTATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)