FDA.reportPublic FDA data

Application 207999

Type
NDA
Sponsor
INTERCEPT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCALIVAOBETICHOLIC ACIDTABLET;ORAL5MGYesNo
002OCALIVAOBETICHOLIC ACIDTABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-005OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent
69516-010OcalivaObeticholic AcidIntercept Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70275SUPPL2022-02-28
70271SUPPL2022-02-28
67660SUPPL2021-06-02
67659SUPPL2021-06-02
67622SUPPL2021-05-28
67617SUPPL2021-05-27
52293SUPPL2018-02-02
52239SUPPL2018-02-01
52238SUPPL2018-02-01
44969ORIG2016-07-08
43542ORIG2016-07-08
40609ORIG2016-05-31
32875ORIG2016-05-31