Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-11-15 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-10-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 7 |
TE Codes
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 79183
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"GEMCITABINE HYDROCHLORIDE","submission":"GEMCITABINE HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)