ANDA 215456

AMNEAL

FDA Drug Application

Application #215456

Application Sponsors

ANDA 215456

AMNEAL

Marketing Status

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

Application Products

001	CAPSULE;ORAL	1MG	0	THIOTHIXENE	THIOTHIXENE
002	CAPSULE;ORAL	2MG	0	THIOTHIXENE	THIOTHIXENE
003	CAPSULE;ORAL	5MG	0	THIOTHIXENE	THIOTHIXENE
004	CAPSULE;ORAL	10MG	0	THIOTHIXENE	THIOTHIXENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215456
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-28
        )

)