Home Applications 073263 Application 073263
Type ANDA
Sponsor UPSHER SMITH LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREVALITE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET No No 002 PREVALITE 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 A073263-001 PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 A073263-002 PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30
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 3 · 84 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 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073263-001 PREVALITE EQ 4GM RESIN/PACKET POWDER / ORAL AB 1996-02-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A073263-002 PREVALITE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 1997-10-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0245-0036 Prevalite cholestyramine Upsher-Smith Laboratories, LLC ANDA Current 0245-0036 Prevalite cholestyramine Upsher-Smith Laboratories, LLC ANDA Current 0245-0036 Prevalite cholestyramine Upsher-Smith Laboratories, LLC ANDA Current