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): 206406
Company: VELOXIS PHARMS INC

Medication Guide

Products on NDA 206406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENVARSUS XR	TACROLIMUS	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ENVARSUS XR	TACROLIMUS	EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ENVARSUS XR	TACROLIMUS	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206406s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206406Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206406Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206406Orig1_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206406s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206406Orig1s010ltr.pdf
04/08/2024	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206406s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206406Orig1s009ltr.pdf
09/16/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206406s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206406Orig1s008ltr.pdf
12/19/2018	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206406s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206406Orig1s007Ltr.pdf
01/06/2017	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/13/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/22/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206406s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206406Orig1s003ltr.pdf
06/07/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/12/2015	SUPPL-1	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206406s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206406Orig1s001ltr.pdf

Labels for NDA 206406

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2024	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206406s009lbl.pdf
04/08/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206406s009lbl.pdf
09/14/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206406s010lbl.pdf
09/16/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206406s008lbl.pdf
12/19/2018	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206406s007lbl.pdf
06/22/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206406s003lbl.pdf
08/12/2015	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206406s001lbl.pdf
07/10/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206406s000lbl.pdf

Top