Home Applications 205750 Application 205750
Type NDA
Sponsor RTRX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHOLBAM CHOLIC ACID CAPSULE;ORAL 50MG Yes No 002 CHOLBAM CHOLIC ACID CAPSULE;ORAL 250MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205750-001 CHOLBAM CHOLIC ACID 50MG CAPSULE / ORAL RLD 2015-03-17 N205750-002 CHOLBAM CHOLIC ACID 250MG CAPSULE / ORAL RLD, RS 2015-03-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N205750-001 CHOLBAM 50MG CAPSULE / ORAL RLD 2015-03-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N205750-002 CHOLBAM 250MG CAPSULE / ORAL RLD, RS 2015-03-17 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHOLBAM CHOLIC ACID Mirum Pharmaceuticals Inc. 5c6e4c9d-b85e-493f-9420-ab2fd0ff3723 2026-01-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 205750 application number: NDA205750
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45043-001 Cholbam Cholic Acid Manchester Pharmaceuticals, LLC NDA Current 45043-001 Cholbam Cholic Acid Retrophin, Inc NDA Current 45043-001 Cholbam Cholic Acid Manchester Pharmaceuticals NDA Current 45043-001 Cholbam Cholic Acid Retrophin, Inc NDA Current 45043-001 Cholbam Cholic Acid Manchester Pharmaceuticals, LLC NDA Current 45043-001 Cholbam Cholic Acid Manchester Pharmaceuticals, LLC NDA Current 45043-002 Cholbam Cholic Acid Manchester Pharmaceuticals, LLC NDA Current 45043-002 Cholbam Cholic Acid Retrophin, Inc NDA Current 45043-002 Cholbam Cholic Acid Manchester Pharmaceuticals NDA Current 45043-002 Cholbam Cholic Acid Retrophin, Inc NDA Current 45043-002 Cholbam Cholic Acid Manchester Pharmaceuticals, LLC NDA Current 45043-002 Cholbam Cholic Acid Manchester Pharmaceuticals, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85993 SUPPL 2026-05-21 85988 SUPPL 2026-05-21 65035 SUPPL 2020-10-27 64993 SUPPL 2020-10-23 43501 ORIG 2015-04-13 32714 ORIG 2015-03-18 19679 ORIG 2015-03-18