NDA 212038

PURDUE PHARMA LP

FDA Drug Application

Application #212038

Documents

• Label: 2019-02-27
• Letter: 2019-02-28
• Review: 2019-07-03
• Letter: 2019-07-05
• Label: 2019-07-10
• Medication Guide: 2019-07-10
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Addendum: 1900-01-01
• Label: 2021-06-28
• Medication Guide: 2021-06-28
• Letter: 2021-06-29
• Label: 2021-06-30
• Medication Guide: 2021-06-30
• Letter: 2021-06-29

Application Sponsors

NDA 212038

PURDUE PHARMA LP

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	25MG	1	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	35MG	1	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	45MG	1	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	55MG	1	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE
005	CAPSULE, EXTENDED RELEASE;ORAL	70MG	1	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE
006	CAPSULE, EXTENDED RELEASE;ORAL	85MG	1	ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-02-27	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2021-06-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-06-25	901 REQUIRED

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	15

CDER Filings

PURDUE PHARMA LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212038
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/212038s001lbl.pdf#page=24"]
            [products] => [{"drugName":"ADHANSIA XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADHANSIA XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"35MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADHANSIA XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"45MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADHANSIA XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"55MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADHANSIA XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"70MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADHANSIA XR","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"85MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/03\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212038s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212038Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/27\/2019","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\\\/2019\\\/212038Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212038Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212038Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/03\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212038s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212038Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-07-03
        )

)