Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216117
Company: OSMOTICA PHARM US

• Medication Guide

Products on NDA 216117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	No
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	No
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	No
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	45MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	No
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	No
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	63MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	No
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	TBD	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216117s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216117Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216117Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216117s001lbl.pdf 216117Orig1s001ltr

Labels for NDA 216117

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216117s001lbl.pdf
06/23/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216117s000lbl.pdf

Therapeutic Equivalents for NDA 216117

RELEXXII

There are no Therapeutic Equivalents.