Details for New Drug Application (NDA): 213301

NDA 213301 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.

Summary for 213301

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

Pharmacology for NDA: 213301

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 213301

Cyclooxygenase 2 Inhibitors

Suppliers and Packaging for NDA: 213301

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CELECOXIB	celecoxib	CAPSULE;ORAL	213301	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-157	29300-157-16	60 CAPSULE in 1 BOTTLE (29300-157-16)
CELECOXIB	celecoxib	CAPSULE;ORAL	213301	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-158	29300-158-01	100 CAPSULE in 1 BOTTLE (29300-158-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jan 12, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jan 12, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jan 12, 2021	TE:		RLD:	No

Complete Access Available with Subscription