ALEMBIC PHARMS LTD FDA Approval ANDA 204445

ANDA 204445

ALEMBIC PHARMS LTD

FDA Drug Application

Application #204445

Application Sponsors

ANDA 204445ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL300MG0LITHIUM CARBONATELITHIUM CARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2015-06-08
LABELING; LabelingSUPPL3AP2020-02-14STANDARD
LABELING; LabelingSUPPL5AP2020-02-14STANDARD
LABELING; LabelingSUPPL8AP2020-07-13STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL5Null7
SUPPL8Null15

TE Codes

001PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204445
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/13\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-13
        )

)

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