LUPIN LTD FDA Approval ANDA 206028

ANDA 206028

LUPIN LTD

FDA Drug Application

Application #206028

Documents

Letter2016-10-03
Label2016-10-11

Application Sponsors

ANDA 206028LUPIN LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL7MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL14MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL21MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORAL28MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-09-28STANDARD
LABELING; LabelingSUPPL3AP2020-06-02STANDARD
LABELING; LabelingSUPPL8AP2020-06-02STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL8Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206028
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"7MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"21MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/28\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206028Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206028Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206028Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/02\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-02
        )

)

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