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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022219
Company: ENDO PHARMS INC

Medication Guide

REMS

Products on NDA 022219

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2014	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022219Orig1AveedTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2022	SUPPL-19	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022219Orig1s019ltr.pdf
06/28/2021	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022219Orig1s016ltr.pdf
08/16/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022219s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022219Orig1s015ltr.pdf
06/30/2020	SUPPL-14	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022219Orig1s014ltr.pdf
03/13/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022219Orig1s013ltr.pdf
12/19/2018	SUPPL-12	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s012ltr.pdf
09/01/2018	SUPPL-11	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s011ltr.pdf
01/24/2018	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s010ltr.pdf
10/25/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022219s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022219Orig1s009.pdf
12/09/2016	SUPPL-8	REMS-Proposal	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s008ltr.pdf
05/11/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022219Orig1s005.pdf
03/03/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s003ltr.pdf
06/19/2014	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022219Orig1s001.pdf

Labels for NDA 022219

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf
01/24/2018	SUPPL-10	Labeling-Package Insert	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

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