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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209863
Company: ANTARES PHARMA INC

Medication Guide

Products on NDA 209863

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	50MG/0.5ML (50MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	75MG/0.5ML (75MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE	100MG/0.5ML (100MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209863

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209863Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209863Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209863s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209863Orig1s020ltr.pdf
11/19/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209863s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209863Orig1s002ltr.pdf

Labels for NDA 209863

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209863s020lbl.pdf
07/11/2025	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209863s020lbl.pdf
11/19/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209863s002lbl.pdf
09/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf

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