ANDA 217066

ZYDUS PHARMS USA INC

FDA Drug Application

Application #217066

Application Sponsors

ANDA 217066

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	INJECTABLE;INJECTION	100MCG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
002	INJECTABLE;INJECTION	200MCG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
003	INJECTABLE;INJECTION	500MCG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217066
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"200MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"500MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-25
        )

)