Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | INJECTABLE;INJECTION | 200MG/5.26ML (38MG/ML) | 0 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | 1GM/26.3ML (38MG/ML) | 0 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE |
003 | INJECTABLE;INJECTION | 2GM/52.6ML (38MG/ML) | 0 | GEMCITABINE HYDROCHLORIDE | GEMCITABINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-04-11 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2019-05-03 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2020-06-23 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 15 |
CDER Filings
ACTAVIS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204549
[companyName] => ACTAVIS INC
[docInserts] => ["",""]
[products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"200MG\/5.26ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1GM\/26.3ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"2GM\/52.6ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/23\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-23
)
)