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Last Updated: August 3, 2021

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Details for New Drug Application (NDA): 207061

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NDA 207061 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-eight 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-two suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 207061
Applicant:Jubilant Generics
Formulation / Manufacturing:see details
Pharmacology for NDA: 207061
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 207061
Suppliers and Packaging for NDA: 207061
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELECOXIB celecoxib CAPSULE;ORAL 207061 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-561 59746-561-01 100 CAPSULE in 1 BOTTLE (59746-561-01)
CELECOXIB celecoxib CAPSULE;ORAL 207061 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-561 59746-561-10 1000 CAPSULE in 1 BOTTLE (59746-561-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Apr 4, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 4, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Apr 4, 2017TE:ABRLD:No

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