Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 010187
Company: NOVARTIS
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf
12/13/2013 SUPPL-77 Labeling-Package Insert 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English