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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208010
Company: EIRGEN

Summary Review

Products on NDA 208010

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAYALDEE	CALCIFEDIOL	0.03MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208010s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208010Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208010Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208010Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2024	SUPPL-13	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208010Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208010Orig1s013ltr.pdf
12/17/2019	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208010s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208010Orig1s005ltr.pdf
12/14/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 208010

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2024	SUPPL-13	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208010Orig1s013lbl.pdf
12/17/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208010s005lbl.pdf
06/17/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208010s000lbl.pdf

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