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Last Updated: June 13, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211412


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NDA 211412 describes CELECOXIB, which is a drug marketed by Acic Pharms, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, 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 Labs Pvt Ltd, Unichem, Watson Labs Inc, and Yiling, and is included in twenty-three NDAs. It is available from forty-seven 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. Fifty-one suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 211412
Tradename:CELECOXIB
Applicant:Yiling
Ingredient:celecoxib
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211412
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 211412
Suppliers and Packaging for NDA: 211412
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 211412 ANDA Yiling Pharmaceutical, Inc. 69117-0020 69117-0020-1 60 CAPSULE in 1 BOTTLE (69117-0020-1)
CELECOXIB celecoxib CAPSULE;ORAL 211412 ANDA Yiling Pharmaceutical, Inc. 69117-0020 69117-0020-2 100 CAPSULE in 1 BOTTLE (69117-0020-2)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 6, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 6, 2020TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG
Approval Date:Mar 6, 2020TE:RLD:No

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