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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 208856


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NDA 208856 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 208856
Tradename:CELECOXIB
Applicant:Qingdao Baheal Pharm
Ingredient:celecoxib
Patents:0
Pharmacology for NDA: 208856
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 208856
Suppliers and Packaging for NDA: 208856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 208856 ANDA Qingdao BAHEAL Pharmaceutical Co., Ltd. 70247-006 70247-006-06 60 CAPSULE in 1 BOTTLE (70247-006-06)
CELECOXIB celecoxib CAPSULE;ORAL 208856 ANDA Qingdao BAHEAL Pharmaceutical Co., Ltd. 70247-007 70247-007-10 100 CAPSULE in 1 BOTTLE (70247-007-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Aug 7, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 7, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Aug 7, 2019TE:ABRLD:No

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