Application 021514
- Type
- NDA
- Sponsor
- NOVEN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAYTRANA | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 10MG/9HR (1.1MG/HR) | Yes | No |
| 002 | DAYTRANA | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 15MG/9HR (1.6MG/HR) | Yes | No |
| 003 | DAYTRANA | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 20MG/9HR (2.2MG/HR) | Yes | No |
| 004 | DAYTRANA | METHYLPHENIDATE | FILM, EXTENDED RELEASE;TRANSDERMAL | 30MG/9HR (3.3MG/HR) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5552 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5553 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5554 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
| 68968-5555 | Daytrana | methylphenidate | Noven Therapeutics, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83511 | SUPPL | 2025-09-25 |
| 83510 | SUPPL | 2025-09-25 |
| 83440 | SUPPL | 2025-09-25 |
| 80474 | SUPPL | 2024-12-03 |
| 80466 | SUPPL | 2024-12-02 |
| 75791 | SUPPL | 2023-10-17 |
| 75758 | SUPPL | 2023-10-16 |
| 72063 | SUPPL | 2022-09-12 |
| 67967 | SUPPL | 2021-06-29 |
| 67966 | SUPPL | 2021-06-29 |
| 67942 | SUPPL | 2021-06-29 |
| 60692 | SUPPL | 2019-10-28 |
| 60634 | SUPPL | 2019-10-23 |
| 56336 | SUPPL | 2018-11-08 |
| 52739 | SUPPL | 2018-02-27 |
| 50409 | SUPPL | 2017-11-14 |
| 50354 | SUPPL | 2017-11-09 |
| 46777 | SUPPL | 2017-01-10 |
| 46717 | SUPPL | 2017-01-06 |
| 45106 | SUPPL | 2016-08-23 |
| 45151 | SUPPL | 2016-08-19 |
| 27992 | SUPPL | 2015-08-18 |
| 37118 | SUPPL | 2015-08-17 |
| 15649 | SUPPL | 2015-04-21 |
| 27991 | SUPPL | 2015-04-20 |
| 15648 | SUPPL | 2013-12-17 |
| 27990 | SUPPL | 2013-12-16 |
| 37117 | SUPPL | 2013-06-07 |
| 27989 | SUPPL | 2013-06-07 |
| 27988 | SUPPL | 2010-10-20 |
| 37116 | SUPPL | 2010-10-18 |
| 15647 | SUPPL | 2010-07-06 |
| 27987 | SUPPL | 2010-07-02 |
| 5594 | SUPPL | 2010-07-02 |
| 27986 | SUPPL | 2009-12-24 |
| 37115 | SUPPL | 2009-12-16 |
| 21708 | ORIG | 2008-11-14 |
| 37114 | SUPPL | 2008-02-14 |
| 37112 | SUPPL | 2008-02-14 |
| 15646 | SUPPL | 2008-02-14 |
| 44132 | ORIG | 2007-05-18 |
| 37113 | SUPPL | 2007-05-07 |
| 5593 | SUPPL | 2007-05-07 |
| 15645 | SUPPL | 2006-08-04 |
| 5592 | SUPPL | 2006-08-04 |
| 27985 | ORIG | 2006-04-13 |
| 54055 | ORIG | 1900-01-01 |
| 53334 | ORIG | 1900-01-01 |
| 53333 | ORIG | 1900-01-01 |
| 53332 | ORIG | 1900-01-01 |