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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 210071


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NDA 210071 describes CELECOXIB, which is a drug marketed by Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Pangea, Pharmobedient, Qingdao Baheal Pharm, Sciegen Pharms, Strides Pharma, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, and Zydus Pharms, and is included in twenty-six NDAs. It is available from sixty-three 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-six suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 210071
Tradename:CELECOXIB
Applicant:Cspc Ouyi
Ingredient:celecoxib
Patents:0
Pharmacology for NDA: 210071
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 210071
Cyclooxygenase 2 Inhibitors
Suppliers and Packaging for NDA: 210071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 210071 ANDA Cranbury Pharmaceuticals, LLC 27808-295 27808-295-01 60 CAPSULE in 1 BOTTLE (27808-295-01)
CELECOXIB celecoxib CAPSULE;ORAL 210071 ANDA Cranbury Pharmaceuticals, LLC 27808-296 27808-296-01 100 CAPSULE in 1 BOTTLE (27808-296-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 23, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 23, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jan 23, 2018TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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