Details for New Drug Application (NDA): 204519

NDA 204519 describes CELECOXIB, which is a drug marketed by Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Norvium Bioscience, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, and Yiling, and is included in twenty-four NDAs. It is available from fifty-nine 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-four suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

Summary for 204519

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

Pharmacology for NDA: 204519

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 204519

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 204519

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELECOXIB	celecoxib	CAPSULE;ORAL	204519	ANDA	medsource pharmaceuticals	45865-943	45865-943-30	30 CAPSULE in 1 BOTTLE (45865-943-30)
CELECOXIB	celecoxib	CAPSULE;ORAL	204519	ANDA	Alembic Pharmaceuticals Limited	46708-267	46708-267-10	100 CAPSULE in 1 CARTON (46708-267-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Aug 21, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Aug 21, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Aug 21, 2015	TE:	AB	RLD:	No

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