Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021514
Company: NOVEN PHARMS INC
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 | AB | Yes | No |
| DAYTRANA | METHYLPHENIDATE | 15MG/9HR (1.6MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | Yes | No |
| DAYTRANA | METHYLPHENIDATE | 20MG/9HR (2.2MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | Yes | No |
| DAYTRANA | METHYLPHENIDATE | 30MG/9HR (3.3MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | 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 |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021514s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021514Orig1s036ltr.pdf | |
| 06/25/2021 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021514s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021514Orig1s032ltr.pdf | |
| 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-Package Insert, Labeling-Medication Guide |
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-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021514Orig1s017.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 |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021514s036lbl.pdf | |
| 06/25/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021514s032lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf | |
| 08/14/2015 | SUPPL-23 | Labeling-Medication Guide | 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf | |
| 12/12/2013 | SUPPL-17 | Labeling-Medication Guide | 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 |
DAYTRANA
FILM, EXTENDED RELEASE;TRANSDERMAL; 10MG/9HR (1.1MG/HR)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DAYTRANA | METHYLPHENIDATE | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB | 021514 | NOVEN PHARMS INC |
| METHYLPHENIDATE | METHYLPHENIDATE | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 206497 | MYLAN TECH VIATRIS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 15MG/9HR (1.6MG/HR)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DAYTRANA | METHYLPHENIDATE | 15MG/9HR (1.6MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB | 021514 | NOVEN PHARMS INC |
| METHYLPHENIDATE | METHYLPHENIDATE | 15MG/9HR (1.6MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 206497 | MYLAN TECH VIATRIS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 20MG/9HR (2.2MG/HR)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DAYTRANA | METHYLPHENIDATE | 20MG/9HR (2.2MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB | 021514 | NOVEN PHARMS INC |
| METHYLPHENIDATE | METHYLPHENIDATE | 20MG/9HR (2.2MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 206497 | MYLAN TECH VIATRIS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 30MG/9HR (3.3MG/HR)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DAYTRANA | METHYLPHENIDATE | 30MG/9HR (3.3MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | Yes | AB | 021514 | NOVEN PHARMS INC |
| METHYLPHENIDATE | METHYLPHENIDATE | 30MG/9HR (3.3MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 206497 | MYLAN TECH VIATRIS |