Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022074
Company: IPSEN PHARMA
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
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
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022074s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022074Orig1s017ltr.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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s011ltr.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)

Label is not available on this site.

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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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