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 )].