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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 213127

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NDA 213127 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 Inc, 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-one 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 213127

Tradename:	CELECOXIB
Applicant:	Strides Pharma
Ingredient:	celecoxib
Patents:	0

Pharmacology for NDA: 213127

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 213127

Cyclooxygenase 2 Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Apr 29, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Apr 29, 2025	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Apr 29, 2025	TE:		RLD:	No

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