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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204684
Company: KNIGHT THERAPS

Products on NDA 204684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMPAVIDO	MILTEFOSINE	50MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204684s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204684Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204684Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204684s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204684Orig1s006ltr.pdf
01/04/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/04/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/10/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204684

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2021	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204684s006lbl.pdf
05/25/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204684s006lbl.pdf
03/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204684s000lbl.pdf

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