Home Applications 204590 Application 204590
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CELECOXIB CELECOXIB CAPSULE;ORAL 50MG No No 002 CELECOXIB CELECOXIB CAPSULE;ORAL 100MG No No 003 CELECOXIB CELECOXIB CAPSULE;ORAL 200MG No No 004 CELECOXIB CELECOXIB CAPSULE;ORAL 400MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204590-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 A204590-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 A204590-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 A204590-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 2026-09-14 22:38:34 2026-08 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204590-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204590-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204590-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204590-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-03-16 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 2 of 2 · 21 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 95 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 33342-155 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-155 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-156 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-156 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-157 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-157 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-158 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 33342-158 celecoxib celecoxib Macleods Pharmaceuticals Limited ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, In ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-967 celecoxib celecoxib PD-Rx Pharmaceuticals, Inc. ANDA Current 51655-253 celecoxib celecoxib Northwind Pharmaceuticals ANDA Current 55700-607 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-607 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-607 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-607 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-613 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-613 celecoxib celecoxib Lake Erie Medical DBA Qua ANDA Current 55700-613 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-613 celecoxib celecoxib Lake Erie Medical DBA Quality Care Products LLC ANDA Current 60760-823 celecoxib celecoxib St. Mary's Medical Park Pharmacy ANDA Current 60760-823 celecoxib celecoxib St. Mary's Medical Park Pharmacy ANDA Current 60760-824 celecoxib celecoxib St. Mary's Medical Park Pharmacy ANDA Current 61919-682 CELECOXIB CELECOXIB DIRECT RX ANDA Current 61919-682 CELECOXIB CELECOXIB Direct_Rx ANDA Current 61919-682 CELECOXIB CELECOXIB Direct_Rx ANDA Current 61919-682 CELECOXIB CELECOXIB Direct_Rx ANDA Current 61919-837 CELECOXIB CELECOXIB DIRECT RX ANDA Current 61919-837 Celecoxib Celecoxib Direct_Rx ANDA Current 61919-837 Celecoxib Celecoxib Direct_Rx ANDA Current 61919-837 Celecoxib Celecoxib Direct_Rx ANDA Current 61919-837 Celecoxib Celecoxib Direct_Rx ANDA Current 61919-837 Celecoxib Celecoxib Direct_Rx ANDA Current 67296-1399 celecoxib celecoxib RedPharm Drug, Inc. ANDA Current 67296-1399 celecoxib celecoxib RedPharm Drug, Inc. ANDA Current 67296-1399 celecoxib celecoxib RedPharm Drug, Inc. ANDA Current 68071-4392 celecoxib celecoxib NuCare Pharmaceuticals,Inc. ANDA Current 68071-4392 celecoxib celecoxib NuCare Pharmaceuticals,Inc. ANDA Current 68788-7264 celecoxib celecoxib Preferred Pharmaceuticals Inc. ANDA Current 68788-7264 celecoxib celecoxib Preferred Pharmaceuticals Inc. ANDA Current 68788-7264 celecoxib celecoxib Preferred Pharmaceuticals Inc. ANDA Current 68788-7286 celecoxib celecoxib Preferred Pharmaceuticals, Inc. ANDA Current 68788-7286 celecoxib celecoxib Preferred Pharmaceuticals, Inc. ANDA Current 68788-7286 celecoxib celecoxib Preferred Pharmaceuticals, Inc. ANDA Current 68788-7286 celecoxib celecoxib Preferred Pharmaceuticals, Inc. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1346 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1650 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-1650 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-2922 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70518-2922 celecoxib celecoxib REMEDYREPACK INC. ANDA Current 70934-220 celecoxib celecoxib Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-220 celecoxib celecoxib Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71205-027 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-027 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-027 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-027 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-027 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-027 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-439 celecoxib celecoxib Proficient Rx LP ANDA Current 71205-439 celecoxib celecoxib Proficient Rx LP ANDA Current 71335-0868 celecoxib celecoxib Bryant Ranch Prepack ANDA Current 71335-0868 celecoxib celecoxib Bryant Ranch Prepack ANDA Current 71335-0936 celecoxib celecoxib Bryant Ranch Prepack ANDA Current 71335-0936 celecoxib celecoxib Bryant Ranch Prepack ANDA Current 72189-123 CELECOXIB CELECOXIB Direct Rx ANDA Current 72189-123 CELECOXIB CELECOXIB Direct Rx ANDA Current 72189-123 CELECOXIB CELECOXIB Direct Rx ANDA Current 76420-009 celecoxib celecoxib Asclemed USA, Inc. ANDA Current