Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021121
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/01/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21121ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-121_Concerta.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/23/2025 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021121s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021121Orig1s053ltr.pdf | |
| 10/13/2023 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021121s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021121Orig1s049ltr.pdf | |
| 06/25/2021 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021121s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021121Orig1s044ltr.pdf | |
| 01/04/2017 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021121Orig1s038ltr.pdf | |
| 11/30/2016 | SUPPL-37 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021121Orig1s037.pdf |
| 04/17/2015 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021121s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021121Orig1s035ltr.pdf | |
| 08/11/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-32 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s032ltr.pdf | |
| 06/12/2013 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s031ltr.pdf | |
| 07/30/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s029ltr.pdf | |
| 11/23/2010 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021121s026,021121s027ltr.pdf | |
| 11/23/2010 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021121s026,021121s027ltr.pdf | |
| 11/04/2009 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021121s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021121s022ltr.pdf | |
| 01/14/2009 | SUPPL-20 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/27/2008 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021121s015, 021121se5-017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021121s017.pdf | |
| 06/27/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021121s015, 021121se5-017ltr.pdf | |
| 05/03/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021121s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021121s014ltr.pdf | |
| 09/07/2006 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021121s009,s012_ltr.pdf | |
| 09/07/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021121s009,s012_ltr.pdf | |
| 10/21/2004 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21121s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21121s008ltr.pdf | |
| 12/18/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/2002 | SUPPL-4 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21121s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021121_S004_CONCERTA_AP.pdf |
| 03/04/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/08/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/23/2025 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021121s053lbl.pdf | |
| 10/13/2023 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021121s049lbl.pdf | |
| 06/25/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021121s044lbl.pdf | |
| 01/04/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf | |
| 04/17/2015 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021121s035lbl.pdf | |
| 12/12/2013 | SUPPL-32 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s032lbl.pdf | |
| 06/12/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s031lbl.pdf | |
| 05/03/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s029lbl.pdf | |
| 11/23/2010 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf | |
| 11/23/2010 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf | |
| 11/04/2009 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021121s022lbl.pdf | |
| 06/27/2008 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf | |
| 06/27/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf | |
| 05/03/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021121s014lbl.pdf | |
| 09/07/2006 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf | |
| 09/07/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf | |
| 10/21/2004 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21121s008lbl.pdf | |
| 08/01/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21121lbl.pdf |
CONCERTA
TABLET, EXTENDED RELEASE;ORAL; 18MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076772 | ACTAVIS LABS FL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | GRANULES |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 36MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076772 | ACTAVIS LABS FL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | GRANULES |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 54MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076655 | ACTAVIS LABS FL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | GRANULES |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 27MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076772 | ACTAVIS LABS FL |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | GRANULES |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |