Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021802
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| 05/26/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021802ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021802s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-41 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021802s038s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/010187Orig1s092; 096; 021284Orig1s042; 046; 021278Orig1s028; 031; 021802Orig1s038; 041ltr | |
| 06/26/2021 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021802s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/010187Orig1s093; 021802Orig1s039; 021284Orig1s043; 021278Orig1s029ltr.pdf | |
| 10/13/2023 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021802s038s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/010187Orig1s092; 096; 021284Orig1s042; 046; 021278Orig1s028; 031; 021802Orig1s038; 041ltr | |
| 11/19/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s026,021802Orig1s036ltr.pdf | |
| 01/04/2017 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021278Orig1s023,021802Orig1s033ltr.pdf | |
| 12/04/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2019 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf | |
| 04/17/2015 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021278Orig1s018,021802Orig1s028ltr.pdf | |
| 06/12/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf | |
| 06/11/2013 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf | |
| 05/02/2012 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf | |
| 04/21/2011 | SUPPL-22 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021802s022lbl.pdf | |
| 11/15/2010 | SUPPL-21 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf | |
| 01/10/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf | |
| 05/04/2010 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s017ltr.pdf | |
| 10/23/2009 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s016ltr.pdf021802s014,s016ltr.pdf | |
| 10/23/2009 | SUPPL-14 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s014,s016ltr.pdf | |
| 10/17/2008 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021802s012ltr.pdf |
| 04/25/2007 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s008,021802s009ltr.pdf | |
| 08/01/2006 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf | |
| 04/11/2006 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf | |
| 08/01/2006 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf | |
| 04/11/2006 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021802s038s041lbl.pdf | |
| 10/13/2023 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021802s038s041lbl.pdf | |
| 10/13/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021802s038s041lbl.pdf | |
| 06/26/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021802s039lbl.pdf | |
| 11/19/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s036lbl.pdf | |
| 01/10/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf | |
| 01/10/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf | |
| 01/04/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf | |
| 04/17/2015 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf | |
| 12/12/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf | |
| 12/12/2013 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf | |
| 06/11/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s025lbl.pdf | |
| 05/02/2012 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf | |
| 04/21/2011 | SUPPL-22 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021802s022lbl.pdf |
| 11/15/2010 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf | |
| 11/15/2010 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf | |
| 05/04/2010 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf | |
| 10/23/2009 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf | |
| 10/23/2009 | SUPPL-14 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf | |
| 04/25/2007 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf | |
| 08/01/2006 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf | |
| 08/01/2006 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf | |
| 08/01/2006 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf | |
| 04/11/2006 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf | |
| 04/11/2006 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf | |
| 05/26/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf |
FOCALIN XR
CAPSULE, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | INTELLIPHARMACEUTICS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | INTELLIPHARMACEUTICS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | INTELLIPHARMACEUTICS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | INTELLIPHARMACEUTICS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | INTELLIPHARMACEUTICS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202731 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | INTELLIPHARMACEUTICS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202731 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 35MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203614 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202731 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | ENDO OPERATIONS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203614 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206734 | SUN PHARM INDS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202731 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |