Home Applications 021176 Application 021176
Type NDA
Sponsor DAIICHI SANKYO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WELCHOL COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021176-001 WELCHOL COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB RLD, RS 2000-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021176-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021176-001 WELCHOL 625MG TABLET / ORAL AB RLD, RS 2000-05-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021176-001 7229613 2022-04-17 U-851 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021176-001 7229613*PED 2022-10-17 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021176-001 7229613 2022-04-17 U-851 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021176-001 7229613*PED 2022-10-17 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021176-001 7229613 2022-04-17 U-851 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021176-001 7229613*PED 2022-10-17 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021176-001 7229613 2022-04-17 U-851 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021176-001 7229613*PED 2022-10-17 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021176-001 7229613 2022-04-17 U-851 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021176-001 7229613*PED 2022-10-17 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021176-001 7229613 2022-04-17 U-851 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021176-001 7229613*PED 2022-10-17 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021176-001 7229613 2022-04-17 U-851 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021176-001 7229613*PED 2022-10-17 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021176-001 7229613 2022-04-17 U-851 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021176-001 7229613*PED 2022-10-17 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021176-001 7229613 2022-04-17 U-851 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021176-001 7229613*PED 2022-10-17 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021176-001 7229613 2022-04-17 U-851 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021176-001 7229613*PED 2022-10-17 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021176-001 7229613 2022-04-17 U-851 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021176-001 7229613*PED 2022-10-17 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021176-001 7229613 2022-04-17 U-851 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021176-001 7229613*PED 2022-10-17 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021176-001 7229613 2022-04-17 U-851 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021176-001 7229613*PED 2022-10-17 Pediatric extension ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021176-001 7229613 2022-04-17 U-851 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021176-001 7229613*PED 2022-10-17 Pediatric extension 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021176-001 7229613 2022-04-17 U-851 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021176-001 7229613*PED 2022-10-17 Pediatric extension 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021176-001 7229613 2022-04-17 U-851 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021176-001 7229613*PED 2022-10-17 Pediatric extension f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021176-001 7229613 2022-04-17 U-851 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021176-001 7229613*PED 2022-10-17 Pediatric extension e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021176-001 7229613 2022-04-17 U-851 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021176-001 7229613*PED 2022-10-17 Pediatric extension cb3db0bc1861…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0713-0879 Welchol colesevelam hydrochloride Cosette Pharmaceuticals, Inc. NDA Current 0713-0879 Welchol colesevelam hydrochloride Cosette Pharmaceuticals, Inc. NDA Current 0713-0936 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE Cosette Pharmaceuticals, Inc. NDA Current 0713-0936 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE Cosette Pharmaceuticals, Inc. NDA Current 0713-0936 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE Cosette Pharmaceuticals, Inc. NDA Current 21695-781 Welchol colesevelam hydrochloride Rebel Distributors Corp NDA Current 51660-996 Colesevelam hydrochloride colesevelam hydrochloride Ohm Laboratories, Inc. NDA Current 51660-996 Colesevelam hydrochloride colesevelam hydrochloride Ohm Laboratories, Inc. NDA Current 51660-996 Colesevelam hydrochloride colesevelam hydrochloride Ohm Laboratories, Inc. NDA Current 51660-996 Colesevelam hydrochloride colesevelam hydrochloride Ohm Laboratories, Inc. NDA Current 51660-996 Colesevelam hydrochloride colesevelam hydrochloride Ohm Laboratories, Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 65597-701 Welchol colesevelam hydrochloride Daiichi Sankyo Inc. NDA Current 68151-4362 Welchol colesevelam hydrochloride Carilion Materials Management NDA Current