NDA 205831

RHODES PHARMS

FDA Drug Application

Application #205831

Documents

• Label: 2015-05-12
• Review: 2015-06-05
• Summary Review: 2015-06-05
• Letter: 2015-04-27
• Label: 2017-01-06
• Letter: 2017-01-10
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-06-17
• Medication Guide: 2019-06-17
• Letter: 2019-06-18
• Pediatric CDTL Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Reissue Amendment 1: 1900-01-01
• Letter: 2021-06-29
• Label: 2021-06-29
• Medication Guide: 2021-06-29

Application Sponsors

NDA 205831

RHODES PHARMS

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	10MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	15MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	20MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	30MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE
005	CAPSULE, EXTENDED RELEASE;ORAL	40MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE
006	CAPSULE, EXTENDED RELEASE;ORAL	50MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE
007	CAPSULE, EXTENDED RELEASE;ORAL	60MG	1	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-09-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-01-04	901 REQUIRED
EFFICACY; Efficacy	SUPPL	5	AP	2019-06-14	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2021-06-25	901 REQUIRED

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	5	Null	31
SUPPL	6	Null	15

TE Codes

001	Prescription	AB3
002	Prescription	AB3
003	Prescription	AB3
004	Prescription	AB3
005	Prescription	AB3
006	Prescription	AB3
007	Prescription	AB3

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205831
            [companyName] => RHODES PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/205831s005lbl.pdf#page=22"]
            [products] => [{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"APTENSIO XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/14\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205831s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205831s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205831s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/17\/2015","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\\\/2015\\\/205831s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205831Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205831Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205831Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/14\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205831s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205831Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205831s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205831Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-14
        )

)