celecoxib 200 MG Oral Capsule
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 is 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 )] .
Torrent Pharmaceuticals Limited
CAPSULE YELLOW 1442 200
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celecoxib 100 mg
Torrent Pharmaceuticals Limited
celecoxib 200 MG Oral Capsule
Torrent Pharmaceuticals Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING
CELECOXIB capsules 50 mg are Size "4", hard gelatin capsule having red opaque cap and red opaque body, imprinted "1307'' on cap and "50" on body with black ink, containing white to off- white granular powder, supplied as: NDC Number Size 13668-307-30 bottle of 30 13668-307-60 bottle of 60 13668-307-90 bottle of 90 13668-307-01 bottle of 100 13668-307-05 bottle of 500 13668-307-10 bottle of 1000 13668-307-31 bottle of 2500
CELECOXIB capsules 100 mg are Size "3", hard gelatin capsule having blue cap and milky white body, imprinted "1441" on cap with white ink and "100" on body with black ink, containing white to off-white granular powder, supplied as: NDC Number Size 13668-441-30 bottle of 30 13668-441-60 bottle of 60 13668-441-90 bottle of 90 13668-441-01 bottle of 100 13668-441-05 bottle of 500 13668-441-10 bottle of 1000 13668-441-19 bottle of 1900
CELECOXIB capsules 200 mg are Size "1'', hard gelatin capsule having yellow opaque cap and yellow opaque body, imprinted "1442" on cap and "200" on body with black ink, containing white to off-white granular powder, supplied as: NDC Number Size 13668-442-30 bottle of 30 13668-442-60 bottle of 60 13668-442-90 bottle of 90 13668-442-01 bottle of 100 13668-442-05 bottle of 500 13668-442-10 bottle of 1000
CELECOXIB capsules 400 mg are Size "0el", hard gelatin capsule having green opaque cap and green opaque body, imprinted "1310" on cap and "400" on body with black ink, containing white to off-white granular powder, supplied as: NDC Number Size 13668-310-30 bottle of 30 13668-310-60 bottle of 60 13668-310-90 bottle of 90 13668-310-01 bottle of 100 13668-310-05 bottle of 500 13668-310-49 bottle of 750 Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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