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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/13/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin.cfm |
Supplements
| 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)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021278s028s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/010187Orig1s092; 096; 021284Orig1s042; 046; 021278Orig1s028; 031; 021802Orig1s038; 041ltr | |
| 06/26/2021 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021278s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/010187Orig1s093; 021802Orig1s039; 021284Orig1s043; 021278Orig1s029ltr.pdf | |
| 10/13/2023 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021278s028s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/010187Orig1s092; 096; 021284Orig1s042; 046; 021278Orig1s028; 031; 021802Orig1s038; 041ltr | |
| 11/19/2019 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s026,021802Orig1s036ltr.pdf | |
| 01/04/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021278Orig1s023,021802Orig1s033ltr.pdf | |
| 05/13/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf | |
| 04/17/2015 | SUPPL-18 | 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 | |
| 12/12/2013 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf | |
| 06/11/2013 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf | |
| 05/02/2012 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021278s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf | |
| 12/09/2010 | SUPPL-13 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf | |
| 11/15/2010 | SUPPL-12 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf | |
| 01/10/2019 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf | |
| 04/25/2007 | SUPPL-8 | 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 | |
| 03/08/2007 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s007ltr.pdf | |
| 08/24/2006 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf | |
| 08/24/2006 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf | |
| 01/03/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf | |
| 12/12/2013 | SUPPL-17 | Labeling-Medication Guide | 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 |
FOCALIN
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 206931 | ABHAI INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 212631 | ALKEM LABS LTD |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 204534 | NOVEL LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 201231 | SUN PHARM INDUSTRIES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207901 | TRIS PHARMA INC |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 021278 | SANDOZ |
TABLET;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 | TABLET;ORAL | Prescription | No | AB | 206931 | ABHAI INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212631 | ALKEM LABS LTD |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209211 | CEDIPROF INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204534 | NOVEL LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201231 | SUN PHARM INDUSTRIES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207901 | TRIS PHARMA INC |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021278 | SANDOZ |
TABLET;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 | TABLET;ORAL | Prescription | No | AB | 206931 | ABHAI INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212631 | ALKEM LABS LTD |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209211 | CEDIPROF INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204534 | NOVEL LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201231 | SUN PHARM INDUSTRIES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207901 | TRIS PHARMA INC |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021278 | SANDOZ |