Application Sponsors
| ANDA 204520 | GLAND PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | 0 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-01-05 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-10-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 17 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204520
[companyName] => GLAND PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 200MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/05\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-03
)
)