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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021475
Company: SPECGX LLC

Medication Guide

Other Important Information from FDA

Products on NDA 021475

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METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021475

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
10/13/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021475s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021475Orig1s012; 021419Orig1s023ltr.pdf
06/25/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021475s011lbl.pdf
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

Labels for NDA 021475

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021475s012lbl.pdf
06/25/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021475s011lbl.pdf
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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