Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213953
Company: MARIUS

• Medication Guide

Products on NDA 213953

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KYZATREX	TESTOSTERONE UNDECANOATE	100MG	CAPSULE;ORAL	Discontinued	None	Yes	No
KYZATREX	TESTOSTERONE UNDECANOATE	150MG	CAPSULE;ORAL	Prescription	None	Yes	No
KYZATREX	TESTOSTERONE UNDECANOATE	200MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213953

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213953s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213953Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213953Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213953s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213953Orig1s005ltr.pdf

Labels for NDA 213953

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213953s005lbl.pdf
07/27/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213953s000lbl.pdf