Home Applications 078555 Application 078555
Type ANDA
Sponsor CASI PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REPAGLINIDE REPAGLINIDE TABLET;ORAL 0.5MG No No 002 REPAGLINIDE REPAGLINIDE TABLET;ORAL 1MG No No 003 REPAGLINIDE REPAGLINIDE TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078555-001 REPAGLINIDE REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 A078555-002 REPAGLINIDE REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 A078555-003 REPAGLINIDE REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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.