Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021475
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLIN METHYLPHENIDATE HYDROCHLORIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
METHYLIN METHYLPHENIDATE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
METHYLIN METHYLPHENIDATE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No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
04/15/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21475_methylin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021475s000_MethylinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021419Orig1s014,021475Orig1s010ltr.pdf
04/17/2015 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021475Orig1s009,021419Orig1s009ltr.pdf
09/15/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s007,021475Orig1s007ltr.pdf
06/14/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s006,021475Orig1s006ltr.pdf
10/18/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021475s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021419s004,021475s005ltr.pdf
06/07/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021419s001,021475s004ltr.pdf
08/10/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021475s002, 021419s003LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf
01/04/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf
04/17/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf
12/12/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s007lbl.pdf
06/14/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021475s006lbl.pdf
10/18/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021475s005lbl.pdf
06/07/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf
08/10/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf
04/15/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21475_methylin_lbl.pdf

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