celecoxib

FDA Drug Profile — celecoxib, CELECOXIB, ELYXYB - celecoxib

celecoxib is listed in the FDA National Drug Code directory with 35 NDC codes, marketed under brand names including celecoxib, CELECOXIB, ELYXYB - celecoxib. Available dosage forms: capsule, powder, liquid.

Drug Details

Generic Name
celecoxib
Brand Names
celecoxib, CELECOXIB, ELYXYB - celecoxib
Application Number
ANDA202240
Sponsor
A-S Medication Solutions
NDC Codes
35
Dosage Forms
CAPSULE, POWDER, LIQUID
Routes
ORAL
Active Ingredients
CELECOXIB

Indications and Usage

1 INDICATIONS AND USAGE Celecoxib is indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ] . 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ] . 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ] . 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [ see Clinical Studies (14.4) ] . 1.5 Acute Pain For the management of acute pain in adults [ see Clinical Studies (14.5) ] . 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies (14.5) ] .