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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208325
Company: KAI PHARMS INC

Products on NDA 208325

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PARSABIV	ETELCALCETIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PARSABIV	ETELCALCETIDE	5MG/ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
PARSABIV	ETELCALCETIDE	10MG/2ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208325Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208325Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2021	SUPPL-5	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208325Orig1s005ltr.pdf
03/08/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208325s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208325Orig1s002ltr.pdf
08/20/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208325s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208325Orig1s001ltr.pdf

Labels for NDA 208325

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208325s002lbl.pdf
08/20/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208325s001lbl.pdf
02/07/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf

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