FDA.reportPublic FDA data

Application 205750

Type
NDA
Sponsor
RTRX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHOLBAMCHOLIC ACIDCAPSULE;ORAL50MGYesNo
002CHOLBAMCHOLIC ACIDCAPSULE;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45043-001CholbamCholic AcidManchester Pharmaceuticals, LLCNDACurrent
45043-001CholbamCholic AcidRetrophin, IncNDACurrent
45043-001CholbamCholic AcidManchester PharmaceuticalsNDACurrent
45043-001CholbamCholic AcidRetrophin, IncNDACurrent
45043-001CholbamCholic AcidManchester Pharmaceuticals, LLCNDACurrent
45043-001CholbamCholic AcidManchester Pharmaceuticals, LLCNDACurrent
45043-002CholbamCholic AcidManchester Pharmaceuticals, LLCNDACurrent
45043-002CholbamCholic AcidRetrophin, IncNDACurrent
45043-002CholbamCholic AcidManchester PharmaceuticalsNDACurrent
45043-002CholbamCholic AcidRetrophin, IncNDACurrent
45043-002CholbamCholic AcidManchester Pharmaceuticals, LLCNDACurrent
45043-002CholbamCholic AcidManchester Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85993SUPPL 2026-05-21
85988SUPPL 2026-05-21
65035SUPPL2020-10-27
64993SUPPL2020-10-23
43501ORIG2015-04-13
32714ORIG2015-03-18
19679ORIG2015-03-18