Cholic Acid Oral Capsule

Brand(s)
Cholbam
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Manchester Pharmaceuticals Inc. (2015-03-23)
Oldest Current Product
2015-03-31
License(s)
NDA
RxNORM
ORAL CAPSULE\CHOLIC ACID
FDAOB
ORAL\CAPSULE\CHOLIC ACID
SPL Active
ORAL\CAPSULE\CHOLIC ACID
SPL Moiety
ORAL\CAPSULE\CHOLIC ACID

product(s) by strength(s)

cholic acid 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1450430002CholbamNDAManchester Pharmaceuticals Inc.2015-03-31CHOLIC ACIDORALCAPSULENDA205750e5b67402-8550-4604-97a0-c7b149fbf753

cholic acid 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1450430001CholbamNDAManchester Pharmaceuticals Inc.2015-03-31CHOLIC ACIDORALCAPSULENDA205750e5b67402-8550-4604-97a0-c7b149fbf753

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA205750CHOLBAMRETROPHIN INC2015-03-17ORPHAN DRUG EXCLUSIVITY [2022-03-17]NDA205750_001, NDA205750_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205750_001RXCHOLIC ACID (50MG)ORALCAPSULEFalse2015-03-17CHOLBAM
2NDA205750_002RXCHOLIC ACID (250MG)ORALCAPSULETrue2015-03-17CHOLBAM

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1e5b67402-8550-4604-97a0-c7b149fbf753 (view SPL)These highlights do not include all the information needed to use CHOLBAM safely and effectively. See full prescribing information for CHOLBAM. CHOLBAM (cholic acid) capsules, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionManchester Pharmaceuticals Inc.2015-03-231450430001, 450430002

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII