Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203255
Company: RECORDATI RARE
Company: RECORDATI RARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 20MG BASE/VIAL | FOR SUSPENSION;INTRAMUSCULAR | Prescription | None | Yes | No |
SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 40MG BASE/VIAL | FOR SUSPENSION;INTRAMUSCULAR | Prescription | None | Yes | No |
SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 60MG BASE/VIAL | FOR SUSPENSION;INTRAMUSCULAR | Prescription | None | Yes | Yes |
SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 10MG BASE/VIAL | FOR SUSPENSION;INTRAMUSCULAR | Prescription | None | Yes | No |
SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 30MG BASE/VIAL | FOR SUSPENSION;INTRAMUSCULAR | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/15/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203255Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2024 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203255s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203255Orig1s011ltr.pdf | |
07/09/2020 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203255Orig1s008ltr.pdf | |
04/11/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203255Orig1s007ltr.pdf | |
01/29/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200677Orig1s004, 203255Orig1s005ltr.pdf | |
06/29/2018 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203255Orig1s004ltr.pdf | |
03/09/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200677Orig1s003,203255Orig1s002ltr.pdf | |
07/08/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/11/2024 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203255s011lbl.pdf | |
07/11/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203255s011lbl.pdf | |
07/09/2020 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf | |
07/09/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf | |
04/11/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf | |
04/11/2019 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf | |
01/29/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s005lbl.pdf | |
06/29/2018 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf | |
03/09/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s002lbl.pdf | |
12/15/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf |