ANDA 211444

PIRAMAL HLTHCARE UK

FDA Drug Application

Application #211444

Application Sponsors

ANDA 211444

PIRAMAL HLTHCARE UK

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 10MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 20MG BASE	0	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PIRAMAL HLTHCARE UK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211444
            [companyName] => PIRAMAL HLTHCARE UK
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-13
        )

)