ANDA 211369

TEVA PHARMS USA INC

FDA Drug Application

Application #211369

Documents

• Letter: 2020-12-07

Application Sponsors

ANDA 211369

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	0.075MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
002	CAPSULE;ORAL	0.15MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
003	CAPSULE;ORAL	0.112MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
004	CAPSULE;ORAL	0.200MG	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211369
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.075MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-28
        )

)