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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213464
Company: BAYER HEALTHCARE

Products on NDA 213464

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMPIT	NIFURTIMOX	30MG	TABLET;ORAL	Prescription	None	Yes	No
LAMPIT	NIFURTIMOX	120MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213464s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213464Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213464Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2023	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213464s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213464Orig1s005ltr.pdf
02/22/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213464s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213464Orig1s004ltr.pdf
01/27/2022	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213464s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213464Orig1s003ltr.pdf
10/02/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213464s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213464Orig1s001ltr.pdf

Labels for NDA 213464

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2023	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213464s005lbl.pdf
02/22/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213464s004lbl.pdf
01/27/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213464s003lbl.pdf
10/02/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213464s001lbl.pdf
08/06/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213464s000lbl.pdf

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