An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 212038
Company: KNOA PHARMA

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.html

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

Top