Details for New Drug Application (NDA): 204197

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NDA 204197 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 sixty 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.

Mechanism of Action	Cyclooxygenase Inhibitors

Cyclooxygenase 2 Inhibitors

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELECOXIB	celecoxib	CAPSULE;ORAL	204197	ANDA	Major Pharmaceuticals	0904-6502	0904-6502-61	100 BLISTER PACK in 1 CARTON (0904-6502-61) / 1 CAPSULE in 1 BLISTER PACK
CELECOXIB	celecoxib	CAPSULE;ORAL	204197	ANDA	Major Pharmaceuticals	0904-6503	0904-6503-61	100 BLISTER PACK in 1 CARTON (0904-6503-61) / 1 CAPSULE in 1 BLISTER PACK

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jun 2, 2015	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jun 2, 2015	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jun 2, 2015	TE:	AB	RLD:	No

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