ANDA 214803

ZYDUS

FDA Drug Application

Application #214803

Application Sponsors

ANDA 214803

ZYDUS

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 0.005MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM
002	TABLET;ORAL	EQ 0.025MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM
003	TABLET;ORAL	EQ 0.05MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214803
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.005MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.025MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.05MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-22
        )

)