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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208171
Company: PHARMACOSMOS AS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONOFERRIC FERRIC DERISOMALTOSE 100MG/ML (100MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
MONOFERRIC FERRIC DERISOMALTOSE 500MG/5ML (100MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
MONOFERRIC FERRIC DERISOMALTOSE 1GM/10ML (100MG/ML) SOLUTION;INTRAVENOUS 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
01/16/2020 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208171Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208171Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2022 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208171Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208171Orig1s002ltr.pdf
09/11/2020 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208171Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/04/2022 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208171Orig1s002lbl.pdf
08/04/2022 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208171Orig1s002lbl.pdf
09/11/2020 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s001lbl.pdf
01/16/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s000lbl.pdf
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