celecoxib 400 mg
1 INDICATIONS & USAGE Celecoxib capsules are indicated Celecoxib capsules are a non-steroidal 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 )] .
Cadila Pharmaceuticals Limited
CAPSULE GREEN C88 400
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celecoxib 200 mg
Cadila Pharmaceuticals Limited
celecoxib 50 mg
Cadila Pharmaceuticals Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB 50 mg capsules are white to off-white powder filled in size "4" hard gelatin capsule with red opaque cap imprinted "C85" and white opaque body imprinted "50", supplied as: NDC Number Size 71209-054-03 bottle of 60 71209-054-11 bottle of 1000
CELECOXIB 100 mg capsules are white to off-white powder filled in size "3" hard gelatin capsule with blue opaque cap imprinted "C86" and white opaque body imprinted "l00", supplied as: NDC Number Size 71209-055-03 bottle of 60 71209-055-05 bottle of 100 71209-055-10 bottle of 500 71209-055-11 bottle of 1000
CELECOXIB 200 mg capsules are white to off-white powder filled in size "2" hard gelatin capsule with gold opaque cap imprinted "C87" and white opaque body imprinted "200", supplied as: NDC Number Size 71209-056-03 bottle of 60 71209-056-05 bottle of 100 71209-056-10 bottle of 500 71209-056-11 bottle of 1000
CELECOXIB 400 mg capsules are white to off-white powder filled in size "00" hard gelatin capsule with green opaque cap imprinted "C88" and white opaque body imprinted "400", supplied as: NDC Number Size 71209-057-03 bottle of 60 71209-057-20 bottle of 600 Storage: Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]
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