Home Applications 020998 Application 020998
Type NDA
Sponsor GD SEARLE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CELEBREX CELECOXIB CAPSULE;ORAL 100MG Yes No 002 CELEBREX CELECOXIB CAPSULE;ORAL 200MG Yes No 003 CELEBREX CELECOXIB CAPSULE;ORAL 400MG Yes Yes 004 CELEBREX CELECOXIB CAPSULE;ORAL 50MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020998-001 CELEBREX CELECOXIB 100MG CAPSULE / ORAL AB RLD 1998-12-31 N020998-002 CELEBREX CELECOXIB 200MG CAPSULE / ORAL AB RLD 1998-12-31 N020998-003 CELEBREX CELECOXIB 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 N020998-004 CELEBREX CELECOXIB 50MG CAPSULE / ORAL AB RLD 2006-12-15
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 · 164 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 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CELEBREX CELECOXIB Viatris Specialty LLC 2d6675e4-5859-4be2-8037-a20ce9f707aa 2024-11-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020998 application number: NDA020998
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 88 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0025-1515 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1515 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1515 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1515 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1515 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1520 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1520 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1520 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1520 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1520 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1525 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1525 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1525 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1525 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1525 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1530 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1530 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1530 CELEBREX Celecoxib Pfizer Laboratories Div Pfizer Inc NDA Current 0025-1530 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 0025-1530 CELEBREX Celecoxib G.D. Searle LLC Division of Pfizer Inc NDA Current 10544-917 Celecoxib Celecoxib Blenheim Pharmacal, Inc. NDA AUTHORIZED GENERIC Current 10544-918 Celecoxib Celecoxib Blenheim Pharmcal, Inc NDA AUTHORIZED GENERIC Current 10544-929 Celecoxib Celecoxib Blenheim Pharmacal, Inc. NDA AUTHORIZED GENERIC Current 10544-967 Celecoxib Celecoxib Blenheim Pharmacal, Inc. NDA AUTHORIZED GENERIC Current 21695-022 CELEBREX Celecoxib Rebel Distributors Corp. NDA Current 21695-023 CELEBREX Celecoxib Rebel Distributors Corp. NDA Current 33261-019 CELEBREX Celecoxib Aidarex Pharmaceuticals LLC NDA Current 43353-036 Celecoxib Celecoxib Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 45865-840 Celecoxib Celecoxib Medsource Pharmaceuticals NDA AUTHORIZED GENERIC Current 45865-840 Celecoxib Celecoxib Medsource Pharmaceuticals NDA AUTHORIZED GENERIC Current 49999-383 CELEBREX Celecoxib Lake Erie Medical DBA Quality Care Products LLC NDA Current 50436-7701 Celecoxib Celecoxib Unit Dose Services NDA AUTHORIZED GENERIC Current 50436-7901 Celecoxib Celecoxib Unit Dose Services NDA AUTHORIZED GENERIC Current 52959-539 CELEBREX Celecoxib H.J. Harkins Company, Inc. NDA Current 52959-540 CELEBREX Celecoxib H.J. Harkins Company, Inc. NDA Current 53217-156 Celecoxib Celecoxib Aidarex Pharmaceuticals LLC NDA AUTHORIZED GENERIC Current 53217-157 Celecoxib Celecoxib Aidarex Pharmaceuticals LLC NDA AUTHORIZED GENERIC Current 55154-3621 CELEBREX Celecoxib Cardinal Health NDA Current 55154-3622 CELEBREX Celecoxib Cardinal Health NDA Current 55154-3625 CELEBREX Celecoxib Cardinal Health NDA Current 55289-451 CELEBREX Celecoxib PD-Rx Pharmaceuticals, In NDA Current 55289-451 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-451 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-451 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-451 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-451 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-475 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-475 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-475 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-475 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 55289-475 CELEBREX Celecoxib PD-Rx Pharmaceuticals, Inc. NDA Current 59762-1515 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1515 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1515 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1516 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1516 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1516 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1517 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1517 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1517 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1518 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1518 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1518 Celecoxib Celecoxib Greenstone LLC NDA AUTHORIZED GENERIC Current 61919-045 CELECOXIB CELECOXIB DIRECT RX NDA Current 61919-046 CELEBREX CELEBREX Direct Rx NDA Current 61919-046 CELEBREX CELEBREX Direct Rx NDA Current 61919-168 CELECOXIB CELECOXIB DirectRX NDA AUTHORIZED GENERIC Current 63187-079 CELEBREX CELECOXIB Proficient Rx LP NDA Current 63187-079 CELEBREX CELECOXIB Proficient Rx LP NDA Current 63187-331 Celecoxib Celecoxib Proficient Rx LP ANDA Current 63629-3021 CELEBREX Celecoxib Bryant Ranch Prepack NDA Current 63629-3021 CELEBREX Celecoxib Bryant Ranch Prepack NDA Current 63629-3021 CELEBREX Celecoxib Bryant Ranch Prepack NDA Current 63629-5503 Celecoxib Celecoxib Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-5504 Celecoxib Celecoxib Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-6368 CELEBREX Celecoxib Bryant Ranch Prepack NDA Current 66336-940 CELEBREX CELECOXIB Dispensing Solutions, Inc. NDA Current 67544-204 CELEBREX Celecoxib Aphena Pharma Solutions - Tennessee, LLC NDA Current 68387-552 CELEBREX Celecoxib Keltman Pharmaceuticals Inc. NDA Current 68788-0768 CELEBREX Celecoxib Preferred Pharmaceuticals, Inc. NDA Current