Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021278
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021278s028s031lbl.pdf | |
| 10/13/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021278s028s031lbl.pdf | |
| 06/26/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021278s029lbl.pdf | |
| 11/19/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s026lbl.pdf | |
| 01/10/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf | |
| 01/10/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf | |
| 01/04/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf | |
| 04/17/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf | |
| 12/12/2013 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf | |
| 12/12/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf | |
| 06/11/2013 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf | |
| 05/02/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021278s015lbl.pdf | |
| 12/09/2010 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf | |
| 12/09/2010 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf | |
| 11/15/2010 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf | |
| 11/15/2010 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf | |
| 04/25/2007 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf | |
| 03/08/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf | |
| 08/24/2006 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf | |
| 08/24/2006 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf | |
| 11/13/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf |