Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021419
Company: SPECGX LLC

• Medication Guide

• Other Important Information from FDA

Products on NDA 21419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Labels for NDA 021419

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021419s023lbl.pdf
10/13/2023	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021419s023lbl.pdf
07/19/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s010lbl.pdf
06/25/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s020lbl.pdf
01/04/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf
01/04/2017	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.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/2013/021419s007lbl.pdf
06/14/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s006lbl.pdf
10/18/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021419s004lbl.pdf
06/07/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf
08/10/2006	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf