ANDA 208749

MAIA PHARMS INC

FDA Drug Application

Application #208749

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

ORIG

1

Null

7

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
        )

)