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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207999
Company: INTERCEPT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCALIVA OBETICHOLIC ACID 5MG TABLET;ORAL Prescription None Yes No
OCALIVA OBETICHOLIC ACID 10MG TABLET;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
05/27/2016 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207999Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207999Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207999Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2022 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207999s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207999Orig1s008ltr.pdf
05/26/2021 SUPPL-7 Labeling-Medication Guide Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207999s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207999Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207999Orig1s007ltr.pdf
02/01/2018 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207999Orig1s003ltr.pdf
12/21/2016 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
02/24/2022 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207999s008lbl.pdf
05/26/2021 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207999s007lbl.pdf
02/01/2018 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf
02/01/2018 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf
02/01/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf
05/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf
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