Application Sponsors
ANDA 208749 | MAIA PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | POWDER;INTRAVENOUS | 100MCG/VIAL | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
002 | POWDER;INTRAVENOUS | 200MCG/VIAL | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
003 | POWDER;INTRAVENOUS | 500MCG/VIAL | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-12-21 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
MAIA PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208749
[companyName] => MAIA PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"200MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"500MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-12-21
)
)