ANDA 214196

AMNEAL

FDA Drug Application

Application #214196

Documents

• Letter: 2021-07-08

Application Sponsors

ANDA 214196

AMNEAL

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	ETRAVIRINE	ETRAVIRINE
002	TABLET;ORAL	100MG	0	ETRAVIRINE	ETRAVIRINE
003	TABLET;ORAL	200MG	0	ETRAVIRINE	ETRAVIRINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214196
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-14
        )

)