Application Sponsors
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
| ORIG | 1 | AP | 2011-07-25 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-10-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
CIPLA
cder:Array
(
[0] => Array
(
[ApplNo] => 78759
[companyName] => CIPLA
[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":"GEMCITABINE HYDROCHLORIDE","submission":"GEMCITABINE HYDROCHLORIDE","actionType":"EQ 200MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GEMCITABINE HYDROCHLORIDE","submission":"GEMCITABINE HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)