Application Sponsors
| ANDA 205241 | GLAND PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 50MG BASE/ML | 0 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE |
| 002 | INJECTABLE;INJECTION | EQ 100MG BASE/ML | 0 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AO |
| 002 | Prescription | AO |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205241
[companyName] => GLAND PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"HALOPERIDOL DECANOATE","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL DECANOATE","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-29
)
)