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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022074
Company: IPSEN PHARMA

Products on NDA 022074

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2007	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022074s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022074s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2023	SUPPL-26		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022074s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022074Orig1s026ltr.pdf
04/11/2019	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022074Orig1s024ltr.pdf
12/12/2018	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022074Orig1s022ltr.pdf
06/14/2019	SUPPL-21	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022074Orig1s021ltr.pdf
10/23/2017	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022074Orig1s018ltr.pdf
09/15/2017	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022074s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022074Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s017.pdf
12/11/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/02/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/01/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/01/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/16/2014	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s011.pdf
12/22/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s010ltr.pdf
10/23/2014	SUPPL-9	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/22074Orig1s009.pdf
02/21/2014	SUPPL-7	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s007.pdf
11/27/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022074Orig1s006ltr.pdf
10/28/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022074Orig1s004.pdf
03/04/2011	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022074s003ltr.pdf

Labels for NDA 022074

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2023	SUPPL-26	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022074s026lbl.pdf
06/14/2019	SUPPL-21	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074Orig1s021lbl.pdf
04/11/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074s024lbl.pdf
12/12/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s022lbl.pdf
02/22/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s018lbl.pdf
09/15/2017	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022074s017lbl.pdf
12/22/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf
12/16/2014	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf
10/28/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf
11/27/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf
03/04/2011	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf
08/30/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf

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