Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010187
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/05/1955 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-96 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/010187s092s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/010187Orig1s092; 096; 021284Orig1s042; 046; 021278Orig1s028; 031; 021802Orig1s038; 041ltr.pdf | |
| 06/26/2021 | SUPPL-93 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/010187Orig1s093; 021802Orig1s039; 021284Orig1s043; 021278Orig1s029ltr.pdf | |
| 10/13/2023 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/010187s092s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/010187Orig1s092; 096; 021284Orig1s042; 046; 021278Orig1s028; 031; 021802Orig1s038; 041ltr | |
| 11/19/2019 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010187Orig1s091,018029Orig1s059,021284Orig1s041ltr.pdf | |
| 01/04/2017 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010187Orig1s087,018029Orig1s055,021284Orig1s034ltr.pdf | |
| 05/27/2016 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2019 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010187Orig1s071s082,018029Oirg1s041s051,021284Oirg1s016s029ltr.pdf | |
| 10/02/2015 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2015 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf | |
| 07/14/2014 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/2013 | SUPPL-77 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf | |
| 02/07/2014 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/2013 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2013 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf | |
| 12/09/2010 | SUPPL-73 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf | |
| 11/15/2010 | SUPPL-72 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf | |
| 01/10/2019 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010187Orig1s071s082,018029Oirg1s041s051,021284Oirg1s016s029ltr.pdf | |
| 04/25/2007 | SUPPL-69 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf | |
| 08/08/2006 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf | |
| 08/08/2006 | SUPPL-66 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf | |
| 06/12/2002 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/2002 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/2002 | SUPPL-60 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf |
| 08/15/2001 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/2004 | SUPPL-58 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf |
| 05/21/2004 | SUPPL-57 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf |
| 01/11/2000 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1998 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1998 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1998 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 12/15/1995 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1994 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1994 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1986 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1985 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1981 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/06/1980 | SUPPL-31 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/09/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1979 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1975 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1975 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1975 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/1975 | SUPPL-21 | Manufacturing (CMC)-Control |
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-96 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/010187s092s096lbl.pdf | |
| 10/13/2023 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/010187s092s096lbl.pdf | |
| 06/26/2021 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf | |
| 11/19/2019 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf | |
| 01/10/2019 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf | |
| 01/10/2019 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf | |
| 01/04/2017 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf | |
| 04/17/2015 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf | |
| 12/13/2013 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf | |
| 12/13/2013 | SUPPL-77 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf | |
| 06/07/2013 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf | |
| 12/09/2010 | SUPPL-73 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf | |
| 11/15/2010 | SUPPL-72 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf | |
| 04/25/2007 | SUPPL-69 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf | |
| 08/08/2006 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf | |
| 08/08/2006 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf |
RITALIN
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |