OSMOTICA PHARM CORP FDA Approval NDA 216117

NDA 216117

OSMOTICA PHARM CORP

FDA Drug Application

Application #216117

Documents

Letter2022-06-24
Label2022-06-24

Application Sponsors

NDA 216117OSMOTICA PHARM CORP

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET, EXTENDED RELEASE;ORAL18MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL27MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL36MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL45MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORAL54MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE
006TABLET, EXTENDED RELEASE;ORAL63MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE
007TABLET, EXTENDED RELEASE;ORAL72MG2RELEXXIIMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-06-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD
004PrescriptionTBD
005PrescriptionTBD
006PrescriptionTBD
007PrescriptionTBD

CDER Filings

OSMOTICA PHARM CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216117
            [companyName] => OSMOTICA PHARM CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"18MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"27MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"36MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"45MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"54MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"63MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"RELEXXII","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"72MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/23\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216117s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/23\/2022","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\\\/2022\\\/216117s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216117Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-06-23
        )

)

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