Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | 100MG | 0 | PEMETREXED DISODIUM | PEMETREXED DISODIUM |
002 | INJECTABLE;INJECTION | 500MG | 0 | PEMETREXED DISODIUM | PEMETREXED DISODIUM |
003 | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL | 0 | PEMETREXED DISODIUM | PEMETREXED DISODIUM |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | TA | 2015-07-31 | |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202111
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/31\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-07-31
)
)