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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 204519


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NDA 204519 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, Nanjing, Norvium Bioscience, 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-nine 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-four suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 204519
Tradename:CELECOXIB
Applicant:Alembic
Ingredient:celecoxib
Patents:0
Pharmacology for NDA: 204519
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 204519
Suppliers and Packaging for NDA: 204519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 204519 ANDA medsource pharmaceuticals 45865-943 45865-943-30 30 CAPSULE in 1 BOTTLE (45865-943-30)
CELECOXIB celecoxib CAPSULE;ORAL 204519 ANDA Alembic Pharmaceuticals Limited 46708-267 46708-267-10 100 CAPSULE in 1 CARTON (46708-267-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Aug 21, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 21, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Aug 21, 2015TE:ABRLD:No

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