ANDA 208698

ALEMBIC PHARMS LTD

FDA Drug Application

Application #208698

Application Sponsors

ANDA 208698

ALEMBIC PHARMS LTD

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	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-09-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	18	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208698
            [companyName] => ALEMBIC PHARMS LTD
            [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":"04\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-05
        )

)