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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213793
Company: RHYTHM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMCIVREE SETMELANOTIDE ACETATE EQ 10MG BASE/ML (EQ 10MG BASE/ML) 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
11/25/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793Orig1s000RPLlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213793Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213793Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2023 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213793s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213793Orig1s005ltr.pdf
06/16/2022 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213793s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213793Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2023 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213793s005lbl.pdf
06/16/2022 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213793s001lbl.pdf
11/25/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793Orig1s000RPLlbl.pdf
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