Home Applications 211316 Application 211316
Type ANDA
Sponsor IMPAX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SEVELAMER CARBONATE SEVELAMER CARBONATE FOR SUSPENSION;ORAL 800MG/PACKET No No 002 SEVELAMER CARBONATE SEVELAMER CARBONATE FOR SUSPENSION;ORAL 2.4GM/PACKET No No
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 A211316-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 A211316-002 SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 1 of 2 · 72 observed 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 2026-02-19 14:30 UTC 2026-02 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2020-11-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2020-11-20 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0115-1365 sevelamer carbonate sevelamer carbonate Amneal Pharmaceuticals of New York LLC ANDA Current 0115-1365 sevelamer carbonate sevelamer carbonate Amneal Pharmaceuticals of New York LLC ANDA Current 0115-1365 sevelamer carbonate sevelamer carbonate Amneal Pharmaceuticals of New York LLC ANDA Current 0115-1366 sevelamer carbonate sevelamer carbonate Amneal Pharmaceuticals of New York LLC ANDA Current 0115-1366 sevelamer carbonate sevelamer carbonate Amneal Pharmaceuticals of New York LLC ANDA Current 0115-1366 sevelamer carbonate sevelamer carbonate Amneal Pharmaceuticals of New York LLC ANDA Current