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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206089
Company: TOLMAR

Medication Guide

Products on NDA 206089

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JATENZO	TESTOSTERONE UNDECANOATE	158MG	CAPSULE;ORAL	Prescription	None	Yes	No
JATENZO	TESTOSTERONE UNDECANOATE	198MG	CAPSULE;ORAL	Prescription	None	Yes	No
JATENZO	TESTOSTERONE UNDECANOATE	237MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206089

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206089s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206089Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/206089Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206089s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206089Orig1s009ltr.pdf
09/12/2025	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206089s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206089Orig1s007ltr.pdf

Labels for NDA 206089

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206089s007lbl.pdf
07/11/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206089s009lbl.pdf
07/11/2025	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206089s009lbl.pdf
03/27/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206089s000lbl.pdf

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