celecoxib

FDA Drug Profile — CELECOXIB, celecoxib, ELYXYB - celecoxib

Drug Details

Generic Name
celecoxib
Brand Names
CELECOXIB, celecoxib, ELYXYB - celecoxib
Application Number
ANDA213127
Sponsor
Viatris Pharmaceuticals LLC
NDC Codes
34
Dosage Forms
POWDER, CAPSULE, LIQUID
Routes
ORAL
Active Ingredients
CELECOXIB

Indications and Usage

1 INDICATIONS AND USAGE 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 ) Celecoxib capsules are indicated 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 )].