Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021514
Company: NOVEN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAYTRANA METHYLPHENIDATE 10MG/9HR (1.1MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
DAYTRANA METHYLPHENIDATE 15MG/9HR (1.6MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
DAYTRANA METHYLPHENIDATE 20MG/9HR (2.2MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes No
DAYTRANA METHYLPHENIDATE 30MG/9HR (3.3MG/HR) FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/06/2006 ORIG-1 Approval Type 2 - New Active Ingredient and Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021514s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021514_daytrana_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2019 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021514s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021514Orig1s030ltr.pdf
11/06/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021514Orig1s028ltr.pdf
01/04/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021514Orig1s025ltr.pdf
08/19/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021514s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021514Orig1s024ltr.pdf
08/14/2015 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021514Orig1s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021514Orig1s023.pdf
04/17/2015 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021514Orig1s022ltr.pdf
04/14/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/14/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/09/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s017ltr.pdf
05/09/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/06/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s015ltr.pdf
11/21/2012 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/18/2010 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s011ltr.pdf
06/29/2010 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s009,s010ltr.pdf
06/29/2010 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s009,s010ltr.pdf
12/15/2009 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021514s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021514s008ltr.pdf
02/05/2008 SUPPL-7 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf
02/05/2008 SUPPL-6 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf
05/01/2007 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021514s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021514s005ltr.pdf
02/05/2008 SUPPL-3 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf
07/27/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021514s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021514s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/22/2019 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021514s030lbl.pdf
11/06/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s028lbl.pdf
01/04/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s025lbl.pdf
08/19/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021514s024lbl.pdf
08/14/2015 SUPPL-23 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf
08/14/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf
04/17/2015 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s022lbl.pdf
12/12/2013 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf
12/12/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf
06/06/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s015lbl.pdf
10/18/2010 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s011lbl.pdf
06/29/2010 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s009s010lbl.pdf
12/15/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021514s008lbl.pdf
02/05/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf
02/05/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf
02/05/2008 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf
05/01/2007 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021514s005lbl.pdf
07/27/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021514s001lbl.pdf

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