FDA.reportPublic FDA data

Application 209946

Type
ANDA
Sponsor
ZHEJIANG JINGXIN

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
A209946-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2020-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209946-001AB

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 22:54:322026-06A209946-001COLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2020-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209946-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEGolden State Medical Supply, Inc.c7058806-ad4f-6d5f-e053-2a95a90a35e82025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209946
application number: ANDA209946
ndc (product): 51407-336
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0f235408-e28d-4cce-b7f1-66bbe0e4534c2025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209946
application number: ANDA209946
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutionsb48a7426-b513-4790-99a4-4f07d83318d72025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209946
application number: ANDA209946
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDECranbury Pharmaceuticals, LLC5e50cc0c-03bc-444b-9d15-ea112bc0f91c2024-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209946
application number: ANDA209946
ndc (product): 27808-190

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
27808-190ColesevelamColesevelamTris Pharma IncANDACurrent
27808-190Colesevelam hydrochlorideColesevelam hydrochlorideTris Pharma IncANDACurrent
51407-336Colesevelam hydrochlorideColesevelam hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-336Colesevelam hydrochlorideColesevelam hydrochlorideGolden State Medical Supply, Inc.ANDACurrent