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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208171
Company: PHARMACOSMOS

Products on NDA 208171

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208171

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
08/01/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208171s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208171Orig1s003ltr.pdf
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

Labels for NDA 208171

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208171s003lbl.pdf
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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