Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018029
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RITALIN-SR METHYLPHENIDATE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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

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