Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018029
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RITALIN-SR | METHYLPHENIDATE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/30/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 11/19/2019 | SUPPL-59 | 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-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018029s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010187Orig1s087,018029Orig1s055,021284Orig1s034ltr.pdf | |
| 12/01/2015 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2019 | SUPPL-51 | 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 | |
| 04/17/2015 | SUPPL-49 | 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 | |
| 12/13/2013 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
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 | |
| 10/25/2013 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2013 | SUPPL-44 | 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-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf | |
| 11/15/2010 | SUPPL-42 | Labeling-Package Insert |
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-41 | 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-40 | 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-38 | 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-37 | 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-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/2002 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/2002 | SUPPL-32 | 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-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/2004 | SUPPL-29 | 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-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf |
| 04/15/1999 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1998 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/15/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 08/19/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1994 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1993 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/09/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1987 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/13/1985 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/14/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1988 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 11/19/2019 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf | |
| 01/10/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf | |
| 01/10/2019 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf | |
| 01/04/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018029s055lbl.pdf | |
| 04/17/2015 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf | |
| 12/13/2013 | SUPPL-47 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf | |
| 12/13/2013 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf | |
| 06/07/2013 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf | |
| 12/09/2010 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf | |
| 11/15/2010 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf | |
| 04/25/2007 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf | |
| 08/08/2006 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf | |
| 08/08/2006 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf |