Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022219
Company: ENDO OPERATIONS

• Medication Guide

• REMS

Products on NDA 22219

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVEED	TESTOSTERONE UNDECANOATE	750MG/3ML (250MG/ML)	INJECTABLE;INTRAMUSCULAR	Prescription	None	Yes	Yes

Labels for NDA 022219

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022219s021lbl.pdf
07/11/2025	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022219s021lbl.pdf
08/16/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022219s015lbl.pdf
06/30/2020	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf
03/13/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s013lbl.pdf
01/24/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf
01/24/2018	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf
10/25/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022219s009lbl.pdf
05/11/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s005lbl.pdf
03/03/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s003lbl.pdf
06/19/2014	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf
06/19/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf
03/05/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf