ALMATICA FDA Approval NDA 215133

NDA 215133

ALMATICA

FDA Drug Application

Application #215133

Documents

Label2021-10-05
Letter2021-10-05
Letter2021-10-05

Application Sponsors

NDA 215133ALMATICA

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE; ORAL150MG0ZERCAPLISERTRALINE HYDROCHORIDE
002CAPSULE; ORAL200MG0ZERCAPLISERTRALINE HYDROCHORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-10-04STANDARD
TYPE 3; Type 3 - New Dosage FormORIG2AP2021-10-04STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null40

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

ALMATICA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215133
            [companyName] => ALMATICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZERCAPLI","activeIngredients":"SERTRALINE HYDROCHORIDE","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ZERCAPLI","activeIngredients":"SERTRALINE HYDROCHORIDE","strength":"200MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/04\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215133s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/04\/2021","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215133s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-04
        )

)

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