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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205739
Company: VIFOR PHARMA

Products on NDA 205739

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 8.4GM BASE/PACKET	POWDER;ORAL	Prescription	None	Yes	No
VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 16.8GM BASE/PACKET	POWDER;ORAL	Prescription	None	Yes	No
VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 25.2GM BASE/PACKET	POWDER;ORAL	Prescription	None	Yes	Yes
VELTASSA	PATIROMER SORBITEX CALCIUM	EQ 1GM BASE/PACKET	POWDER;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205739

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205739Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2023	SUPPL-38	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205739Orig1s038lbl.pdf
03/27/2023	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205739s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205739Orig1s037ltr.pdf
12/22/2021	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205739s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205739Orig1s035ltr.pdf
05/14/2021	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205739s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205739Orig1s031ltr.pdf
05/02/2018	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205739Orig1s016ltr.pdf
12/01/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/25/2016	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s009ltr.pdf
06/16/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/10/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/20/2016	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s001ltr.pdf

Labels for NDA 205739

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2023	SUPPL-38	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205739Orig1s038lbl.pdf
03/27/2023	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205739s037lbl.pdf
12/22/2021	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205739s035lbl.pdf
05/14/2021	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205739s031lbl.pdf
05/02/2018	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf
11/25/2016	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf
11/25/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf
05/20/2016	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf
05/20/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf
10/21/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf

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