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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022505
Company: THERATECHNOLOGIES

Summary Review

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 022505

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EGRIFTA	TESAMORELIN ACETATE	EQ 1MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	None	No	No
EGRIFTA	TESAMORELIN ACETATE	EQ 2MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022505

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2010	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022505s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2024	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022505Orig1s018ltr.pdf
07/05/2019	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012, s013ltr.pdf
07/05/2019	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012, s013ltr.pdf
01/18/2019	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s011ltr.pdf
	SUPPL-10	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf
06/08/2015	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022505Orig1s007ltr.pdf
02/09/2015	SUPPL-6	Supplement		Label is not available on this site.
12/15/2014	SUPPL-5	Supplement		Label is not available on this site.
01/07/2013	SUPPL-4	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf
11/29/2011	SUPPL-3	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
11/29/2011	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf

Labels for BLA 022505

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2024	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf
02/27/2024	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf
02/27/2024	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf
07/05/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019	SUPPL-12	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
01/18/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf
06/08/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf
01/07/2013	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf
11/29/2011	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
11/29/2011	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
11/10/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf
	SUPPL-10	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf

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