Application 210895
- Type
- NDA
- Sponsor
- DAIICHI SANKYO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WELCHOL | COLESEVELAM HYDROCHLORIDE | BAR, CHEWABLE;ORAL | 3.75GM | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210895-001 | WELCHOL | COLESEVELAM HYDROCHLORIDE | 3.75GM | BAR, CHEWABLE / ORAL | RLD | 2019-04-03 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N210895-001 | WELCHOL | 3.75GM | BAR, CHEWABLE / ORAL | RLD | 2019-04-03 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | Bryant Ranch Prepack | dbed6967-b261-44a1-bee4-638810e2efe9 | 2026-05-26 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | Bionpharma Inc. | 4aa52225-9214-59dc-e063-6294a90a5f75 | 2026-02-12 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 845b8661-0aa9-418f-a496-df3d7a3130ff | 2026-01-29 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam Hydrochloride | COLESEVELAM HYDROCHLORIDE | Glenmark Pharmaceuticals Inc.,USA | 2e736dd4-bb64-4f93-9821-7c24ea7d38ec | 2026-01-28 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | Golden State Medical Supply, Inc. | c7058806-ad4f-6d5f-e053-2a95a90a35e8 | 2025-12-10 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam Hydrochloride | COLESEVELAM HYDROCHLORIDE | American Health Packaging | 87bf6310-cfc4-4cb4-966e-8561b3880e36 | 2025-12-05 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | A-S Medication Solutions | 0f235408-e28d-4cce-b7f1-66bbe0e4534c | 2025-07-17 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | A-S Medication Solutions | b48a7426-b513-4790-99a4-4f07d83318d7 | 2025-07-16 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam Hydrochloride | COLESEVELAM HYDROCHLORIDE | Macleods Pharmaceuticals Limited | c2075dd1-e33c-4438-95f8-1897f0e1f61a | 2025-05-05 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | Bionpharma Inc. | a2c5e881-2901-4f90-95cc-74930569e51e | 2025-03-19 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | A-S Medication Solutions | 67820d4f-0cfb-43ca-8974-08dffe474983 | 2024-11-18 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | A-S Medication Solutions | 79af88a5-b873-499b-a9a4-fc39624820fe | 2024-11-18 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam Hydrochloride | COLESEVELAM HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | f5306376-e7f2-44ad-8250-635b95428a7c | 2024-10-29 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | Cranbury Pharmaceuticals, LLC | 5e50cc0c-03bc-444b-9d15-ea112bc0f91c | 2024-07-31 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | Bryant Ranch Prepack | 652fbd7b-2702-4db6-8691-be93c61bd9d6 | 2024-07-25 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | A-S Medication Solutions | 0127afae-8d8d-43f2-97f9-4f99f6947e81 | 2023-12-28 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | A-S Medication Solutions | 40d66c9d-ff51-4353-8133-ae3a8eb4f713 | 2023-12-28 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam Hydrochloride | COLESEVELAM HYDROCHLORIDE | Dr.Reddys Laboratories Inc | 28701657-640a-67d6-e56f-cf5c672c6e2a | 2023-06-30 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | Ascend Laboratories, LLC | dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96 | 2023-02-16 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
| Colesevelam hydrochloride | COLESEVELAM HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | f33fbf30-2486-49a7-bbe8-0ddfb4b9b786 | 2022-10-18 | Warnings, Adverse reactions | COLESEVELAM HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65597-208 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-208 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-208 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-209 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-209 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-209 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-210 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-210 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-210 | Welchol | colesevelam hydrochloride | Daiichi Sankyo Inc. | NDA | Current |