ALMATICA FDA Approval NDA 215429

NDA 215429

ALMATICA

FDA Drug Application

Application #215429

Documents

Letter2022-06-30
Letter2022-06-30
Label2022-06-30
Label2022-06-30
Medication Guide2022-06-30
Medication Guide2022-06-30

Application Sponsors

NDA 215429ALMATICA

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE; ORAL112.5MG0VENBYSI XRVENLAFAXINE BESYLATE

FDA Submissions

TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage FormORIG1AP2022-06-29STANDARD
TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage FormORIG2AP2022-06-29STANDARD

Submissions Property Types

ORIG1Null40
ORIG2Null15

CDER Filings

ALMATICA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215429
            [companyName] => ALMATICA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/215429s000lbl.pdf#page=31"]
            [products] => [{"drugName":"VENBYSI XR","activeIngredients":"VENLAFAXINE BESYLATE","strength":"112.5MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/29\/2022","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/29\/2022","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient and Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215429Orig1s000,215429Orig2s000ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient and Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215429s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215429Orig1s000,215429Orig2s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-06-29
        )

)

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