Drugs@FDA: FDA-Approved Drugs
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 | AB | Yes | Yes |
SOMATULINE DEPOT | LANREOTIDE ACETATE | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOLUTION;SUBCUTANEOUS | Prescription | AB | Yes | Yes |
SOMATULINE DEPOT | LANREOTIDE ACETATE | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | AB | 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 |
---|---|---|---|---|---|
07/11/2024 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022074s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022074Orig1s032ltr.pdf | |
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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/11/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022074s032lbl.pdf | |
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 |
SOMATULINE DEPOT
SOLUTION;SUBCUTANEOUS; EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANREOTIDE ACETATE | LANREOTIDE ACETATE | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AB | 217193 | INVAGEN PHARMS |
SOMATULINE DEPOT | LANREOTIDE ACETATE | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AB | 022074 | IPSEN PHARMA |
SOLUTION;SUBCUTANEOUS; EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANREOTIDE ACETATE | LANREOTIDE ACETATE | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AB | 217193 | INVAGEN PHARMS |
SOMATULINE DEPOT | LANREOTIDE ACETATE | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AB | 022074 | IPSEN PHARMA |
SOLUTION;SUBCUTANEOUS; EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANREOTIDE ACETATE | LANREOTIDE ACETATE | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AB | 217193 | INVAGEN PHARMS |
SOMATULINE DEPOT | LANREOTIDE ACETATE | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AB | 022074 | IPSEN PHARMA |