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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204197


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NDA 204197 describes CELECOXIB, which is a drug marketed by Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Nanjing, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, and Yiling, and is included in twenty-four NDAs. It is available from fifty-eight suppliers. Additional details are available on the CELECOXIB profile page.

The generic ingredient in CELECOXIB is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 204197
Tradename:CELECOXIB
Applicant:Apotex
Ingredient:celecoxib
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204197
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 204197
Suppliers and Packaging for NDA: 204197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 204197 ANDA Major Pharmaceuticals 0904-6502 0904-6502-61 100 BLISTER PACK in 1 CARTON (0904-6502-61) / 1 CAPSULE in 1 BLISTER PACK
CELECOXIB celecoxib CAPSULE;ORAL 204197 ANDA Major Pharmaceuticals 0904-6503 0904-6503-61 100 BLISTER PACK in 1 CARTON (0904-6503-61) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jun 2, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 2, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jun 2, 2015TE:ABRLD:No

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