FDA.reportPublic FDA data

Application 020926

Type
NDA
Sponsor
GENZYME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RENAGELSEVELAMER HYDROCHLORIDECAPSULE;ORAL403MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020926-001RENAGELSEVELAMER HYDROCHLORIDE403MGCAPSULE / ORAL1998-10-30

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020926-001RENAGEL403MGCAPSULE / ORAL1998-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020926-001RENAGEL403MGCAPSULE / ORAL1998-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020926-001RENAGEL403MGCAPSULE / ORAL1998-10-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020926-001RENAGEL403MGCAPSULE / ORAL1998-10-30a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer HydrochlorideSEVELAMER HYDROCHLORIDEAmerican Health Packaging8830526f-d957-423e-84ea-e4d79346948b2026-06-25Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochlorideSEVELAMER HYDROCHLORIDECardinal Health 107, LLCc13532a7-4c56-4084-839d-3dcfd4dc30f82026-02-26Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochlorideSEVELAMER HYDROCHLORIDEMajor Pharmaceuticals0500034d-458c-42c5-918d-9acd22f0c28b2026-02-13Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochlorideSEVELAMER HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA2cd6512f-0edd-4a30-a4fa-aa996038633c2026-01-27Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
Sevelamer hydrochlorideSEVELAMER HYDROCHLORIDELupin Pharmaceuticals, Inc.a56c857e-bc39-484c-908d-f5957857efbb2025-07-22Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
Sevelamer HydrochlorideSEVELAMER HYDROCHLORIDEBryant Ranch Prepack35337152-9b92-40c0-e063-6294a90a8dd52025-05-15Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
Sevelamer HydrochlorideSEVELAMER HYDROCHLORIDEBryant Ranch Prepack3533d24b-508e-f012-e063-6394a90acaf52025-05-15Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
Sevelamer HydrochlorideSEVELAMER HYDROCHLORIDEZydus Pharmaceuticals USA Inc.ddecb552-5882-4e44-8fa7-37c9234dd1b92025-02-05Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
SEVELAMER HYDROCHLORIDESEVELAMER HYDROCHLORIDEAurobindo Pharma Limitedd8729e42-dbbd-4954-9ce0-298743a15a062024-01-24Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE
Sevelamer HydrochlorideSEVELAMER HYDROCHLORIDEMacleods Pharmaceuticals Limited6926ebbe-2d74-4d5f-b642-c1bfe3a4e3052023-06-05Warnings, Adverse reactionsName fallback
generic name: SEVELAMER HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
26209SUPPL2004-03-03
26208SUPPL2000-05-05
21278ORIG1999-07-04
26207ORIG1998-10-30
13749ORIG1998-10-30