Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021121
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
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
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 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
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 208607 ANI PHARMS INC
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 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA

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 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
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 208607 ANI PHARMS INC
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 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204659 PAR PHARM

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 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
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 208607 ANI PHARMS INC
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 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204659 PAR PHARM

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 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
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 208607 ANI PHARMS INC
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 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA

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