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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212564


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NDA 212564 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 sixty 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-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 212564
Tradename:CELECOXIB
Applicant:Yabao Pharm
Ingredient:celecoxib
Patents:0
Pharmacology for NDA: 212564
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 212564
Suppliers and Packaging for NDA: 212564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 212564 ANDA Yabao Pharmaceutical Co., Ltd. Beijing 51990-033 51990-033-01 100 CAPSULE in 1 BOTTLE (51990-033-01)
CELECOXIB celecoxib CAPSULE;ORAL 212564 ANDA Yabao Pharmaceutical Co., Ltd. Beijing 51990-033 51990-033-02 500 CAPSULE in 1 BOTTLE (51990-033-02)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 10, 2023TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG
Approval Date:Apr 10, 2023TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength400MG
Approval Date:Apr 10, 2023TE:RLD:No

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