NDA 216117

OSMOTICA PHARM CORP

FDA Drug Application

Application #216117

Documents

• Letter: 2022-06-24
• Label: 2022-06-24

Application Sponsors

NDA 216117

OSMOTICA PHARM CORP

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	18MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	27MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	36MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	45MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	54MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	63MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE
007	TABLET, EXTENDED RELEASE;ORAL	72MG	2	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-06-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD
004	Prescription	TBD
005	Prescription	TBD
006	Prescription	TBD
007	Prescription	TBD

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
        )

)