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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207999
Company: INTERCEPT PHARMS INC

Medication Guide

Summary Review

Products on NDA 207999

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OCALIVA	OBETICHOLIC ACID	5MG	TABLET;ORAL	Prescription	AB	Yes	No
OCALIVA	OBETICHOLIC ACID	10MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207999

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.

Labels for NDA 207999

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

Therapeutic Equivalents for NDA 207999

OCALIVA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OCALIVA	OBETICHOLIC ACID	5MG	TABLET;ORAL	Prescription	Yes	AB	207999	INTERCEPT PHARMS INC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OCALIVA	OBETICHOLIC ACID	10MG	TABLET;ORAL	Prescription	Yes	AB	207999	INTERCEPT PHARMS INC

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