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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212038
Company: PURDUE PHARMA LP

Medication Guide

Products on NDA 212038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	45MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	55MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	70MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ADHANSIA XR	METHYLPHENIDATE HYDROCHLORIDE	85MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212038Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212038Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212038Orig1s005ltr.pdf
06/28/2021	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212038Orig1s002ltr.pdf
07/03/2019	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212038Orig1s001ltr.pdf

Labels for NDA 212038

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2021	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf
06/25/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s005lbl.pdf
07/03/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf
02/27/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038Orig1s000lbl.pdf

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