Application Sponsors
ANDA 206086 | SAVIOR LIFETEC CORP | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 500MG/VIAL | 0 | MEROPENEM | MEROPENEM |
002 | INJECTABLE;INJECTION | 1GM/VIAL | 0 | MEROPENEM | MEROPENEM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-04-19 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
SAVIOR LIFETEC CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 206086
[companyName] => SAVIOR LIFETEC CORP
[docInserts] => ["",""]
[products] => [{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-04-19
)
)