Documents
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
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
)
)