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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205489
Company: NEOS THERAPS INC

Medication Guide

Products on NDA 205489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COTEMPLA XR-ODT	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
COTEMPLA XR-ODT	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
COTEMPLA XR-ODT	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
COTEMPLA XR-ODT	METHYLPHENIDATE	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205489Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205489Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205489s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/205489Orig1s021ltr.pdf
03/12/2024	SUPPL-16	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205489Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205489Orig1s016ltr.pdf
10/13/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205489s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205489Orig1s012ltr.pdf
06/25/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205489Orig1s007ltr.pdf

Labels for NDA 205489

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205489s021lbl.pdf
09/23/2025	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205489s021lbl.pdf
03/12/2024	SUPPL-16	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205489Orig1s016lbl.pdf
10/13/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205489s012lbl.pdf
06/25/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf
06/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf

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