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
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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