Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208010
Company: EIRGEN
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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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