Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207999
Company: INTERCEPT PHARMS INC
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 | AB | Yes | No |
OCALIVA | OBETICHOLIC ACID | 10MG | TABLET;ORAL | Prescription | AB | 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-Medication Guide, Labeling-Container/Carton Labels, 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.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-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 |
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 |