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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021259
Company: LANNETT

Medication Guide

Other Important Information from FDA

Products on NDA 21259

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	Yes	No
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	Yes	No
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	Yes	No
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	Yes	No
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	Yes	No
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB2	Yes	Yes

Labels for NDA 021259

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-36	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021259s036lbl.pdf
09/23/2025	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021259s036lbl.pdf
10/13/2023	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021259s034lbl.pdf
04/22/2022	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021259s025lbl.pdf
06/25/2021	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021259s032lbl.pdf
01/04/2017	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf
04/17/2015	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021259s029lbl.pdf
12/13/2013	SUPPL-27	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf
12/13/2013	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf
06/04/2013	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf
05/06/2013	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s024lbl.pdf
05/06/2013	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s023lbl.pdf
10/18/2010	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf
04/16/2009	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021259s021lbl.pdf
08/26/2008	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021259s019lbl.pdf
05/04/2007	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf
08/10/2006	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021259s018lbl.pdf
04/09/2002	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf
04/03/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf

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