Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 18MG | 1 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | 36MG | 1 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE |
003 | TABLET, EXTENDED RELEASE;ORAL | 54MG | 1 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE |
004 | TABLET, EXTENDED RELEASE;ORAL | 27MG | 1 | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-08-01 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2001-04-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-03-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-04-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-12-18 | STANDARD |
EFFICACY; Efficacy | SUPPL | 8 | AP | 2004-10-21 | PRIORITY |
LABELING; Labeling | SUPPL | 9 | AP | 2006-09-07 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2006-09-07 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2007-05-03 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2008-06-27 | STANDARD |
EFFICACY; Efficacy | SUPPL | 17 | AP | 2008-06-27 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2009-01-14 | N/A |
EFFICACY; Efficacy | SUPPL | 22 | AP | 2009-11-04 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2010-11-23 | UNKNOWN |
LABELING; Labeling | SUPPL | 27 | AP | 2010-11-23 | UNKNOWN |
LABELING; Labeling | SUPPL | 29 | AP | 2013-05-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2013-07-30 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2013-06-12 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2013-12-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2014-08-11 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2015-04-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2016-11-30 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2017-01-04 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 44 | AP | 2021-06-25 | 901 REQUIRED |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 6 |
SUPPL | 22 | Null | 7 |
SUPPL | 26 | Null | 6 |
SUPPL | 27 | Null | 6 |
SUPPL | 29 | Null | 15 |
SUPPL | 30 | Null | 0 |
SUPPL | 31 | Null | 6 |
SUPPL | 32 | Null | 7 |
SUPPL | 33 | Null | 0 |
SUPPL | 35 | Null | 7 |
SUPPL | 38 | Null | 15 |
SUPPL | 44 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21121
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021121s044lbl.pdf#page=30"]
[products] => [{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"18MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"36MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"54MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CONCERTA","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"27MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"06\/25\/2021","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021121s044lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021121s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021121s035lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021121s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021121s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2013","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021121s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021121s026s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2010","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021121s026s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2009","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021121s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2008","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021121s015s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021121s015s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021121s014lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2006","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021121s009s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021121s009s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2004","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21121s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21121lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"18MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"36MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"54MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CONCERTA","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"27MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-06-25
)
)