FDA.reportPublic FDA data

Application 208670

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDETABLET;ORAL625MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208670-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2019-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208670-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208670-001COLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2019-09-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208670-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEBionpharma Inc.4aa52225-9214-59dc-e063-6294a90a5f752026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208670
application number: ANDA208670
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEBionpharma Inc.a2c5e881-2901-4f90-95cc-74930569e51e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208670
application number: ANDA208670
ndc (product): 69452-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2446COLESEVELAM HYDROCHLORIDEcolesevelam hydrochlorideBryant Ranch PrepackANDACurrent
63629-2446COLESEVELAM HYDROCHLORIDEcolesevelam hydrochlorideBryant Ranch PrepackANDACurrent
69452-158COLESEVELAM HYDROCHLORIDEcolesevelam hydrochlorideBionpharma Inc.ANDACurrent
69452-158COLESEVELAM HYDROCHLORIDEcolesevelam hydrochlorideBionpharma Inc.ANDACurrent