AJANTA PHARMA LTD FDA Approval ANDA 208706

ANDA 208706

AJANTA PHARMA LTD

FDA Drug Application

Application #208706

Application Sponsors

ANDA 208706AJANTA PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
002CAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
003CAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
004CAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASE0DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-01-06STANDARD
LABELING; LabelingSUPPL3AP2022-07-29STANDARD
LABELING; LabelingSUPPL6AP2022-07-29STANDARD
LABELING; LabelingSUPPL25AP2022-07-29STANDARD
LABELING; LabelingSUPPL29AP2022-07-29STANDARD
LABELING; LabelingSUPPL42AP2022-07-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL49AP2022-07-26UNKNOWN
LABELING; LabelingSUPPL51AP2022-07-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL6Null7
SUPPL25Null7
SUPPL29Null7
SUPPL42Null31
SUPPL49Null15
SUPPL51Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208706
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-06
        )

)

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