Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076898

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NDA 076898 describes CELECOXIB, which is a drug marketed by Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin, Macleods Pharms, Micro Labs, Nanjing, Pangea, Pharmazone, Pharmobedient, Qingdao Baheal Pharm, Sciegen Pharms, Strides Pharma, Teva, Tianjin Tianyao, Torrent, Unichem, Watson Labs Inc, Yabao Pharm, and Zydus Pharms, and is included in twenty-six NDAs. It is available from sixty-two suppliers. Additional details are available on the CELECOXIB profile page.

The generic ingredient in CELECOXIB is celecoxib. There is one drug master file entry for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

Summary for 076898

Tradename:	CELECOXIB
Applicant:	Teva
Ingredient:	celecoxib
Patents:	0

Medical Subject Heading (MeSH) Categories for 076898

Cyclooxygenase 2 Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	May 30, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	May 30, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	May 30, 2014	TE:	AB	RLD:	No

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