Home Applications 214877 Application 214877
Type ANDA
Sponsor UPSHER SMITH LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET No No 002 CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A214877-001 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2022-01-21 A214877-002 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2022-01-21
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 · 66 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 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2022-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2022-01-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2022-01-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2022-01-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2022-01-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2022-01-21 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214877-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL 2022-01-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214877-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL 2022-01-21 6a51e52b5d6a…
Observed Orange Book normalized TE history# 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 2 · 23 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cholestyramine CHOLESTYRAMINE Bryant Ranch Prepack cc447b99-e654-42dd-8cf1-f9e7952a25cd 2026-07-16 Warnings, Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Bryant Ranch Prepack b26a13e9-42a2-4869-a00a-672bb1ac4742 2026-07-13 Warnings, Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Bryant Ranch Prepack 2998a314-deb2-4a02-afab-7e8c868888e2 2026-07-13 Warnings, Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Par Health USA, LLC b0c65058-22c3-4f57-9b61-9bc6fcd6e240 2026-06-15 Warnings, Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE CHOLESTYRAMINE CHOLESTYRAMINE EPIC PHARMA, LLC d02eca8c-18d4-4b11-bb16-08748543b04d 2026-06-15 Adverse reactions Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE CHOLESTYRAMINE CHOLESTYRAMINE Zydus Pharmaceuticals (USA) Inc. acc48703-c15b-4275-aa75-749f1c07dcbb 2026-04-28 Adverse reactions Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE CHOLESTYRAMINE CHOLESTYRAMINE Zydus Lifesciences Limited a86715e3-741f-47c6-9682-1413f0f8ff0c 2026-04-28 Adverse reactions Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Micro Labs Limited 09420793-7357-4194-8172-0b1cddb167fe 2026-03-05 Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE CHOLESTYRAMINE CHOLESTYRAMINE EPIC PHARMA, LLC d931e372-2477-4554-912e-9d4d7d538ce2 2025-12-17 Adverse reactions Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE CHOLESTYRAMINE CHOLESTYRAMINE EPIC PHARMA, LLC c65e556a-3b6a-4466-a7ce-5b24103ed8ad 2025-12-17 Adverse reactions Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE CHOLESTYRAMINE CHOLESTYRAMINE PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS d82647da-465b-4e2e-8cf8-72d50f047b3e 2025-12-11 Adverse reactions Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Macleods Pharmaceuticals Limited 8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b 2025-12-09 Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Prevalite CHOLESTYRAMINE Upsher-Smith Laboratories, LLC dd434ef8-8af3-434c-a0a0-9a0b18459ba0 2025-12-02 Warnings, Adverse reactions Name fallback generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Ajanta Pharma USA Inc. a0b64dfe-49bc-45d7-9281-9e9d6e296c40 2025-10-08 Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE TAGI Pharma, Inc. 06261db5-1435-4b91-8b54-71bfcfb1368c 2025-04-17 Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Cholestyramine Light CHOLESTYRAMINE TAGI Pharma, Inc. eb85a2c8-cdc3-48bb-844d-e220ae3701a0 2025-04-17 Warnings, Adverse reactions Name fallback generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Precision Dose, Inc. 8c7fc9c8-318c-42de-a736-c439047d8af8 2025-03-12 Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Macleods Pharmaceuticals Limited c41529f1-16d2-4ca3-91eb-f809571f5ae3 2025-01-30 Warnings, Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE QUESTRAN CHOLESTYRAMINE Endo USA, Inc. 362ddd91-a63f-4ec6-841a-75785dd208c8 2024-11-28 Warnings, Adverse reactions Name fallback generic name: CHOLESTYRAMINE Cholestyramine CHOLESTYRAMINE Bryant Ranch Prepack c58d6bd9-0273-4c16-8533-495170413d8c 2024-08-23 Warnings, Adverse reactions Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0832-0536 Cholestyramine Cholestyramine Upsher-Smith Laboratories,LLC ANDA Current