Celecoxib 50 Mg

Product manufactured by Sydon Labs Llc

Application Nr Approved Date Route Status External Links
ANDA204519 2015-08-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Carefully Consider The Potential Benefits And Risks Of Celecoxib And Other Treatment Options Before Deciding To Use Celecoxib. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals [see Warnings And Precautions (5)] Celecoxib Is A Nonsteroidal Anti-Inflammatory Drug Indicated For: Osteoarthritis (oa) (1.1)r 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) Celecoxib Is Indicated For Relief Of The Signs And Symptoms Of Oa [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (ra) Celecoxib Is Indicated For Relief Of The Signs And Symptoms Of Ra [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis (jra) Celecoxib Is Indicated For Relief Of The Signs And Symptoms Of Jra In Patients 2 Years And Older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis (as) Celecoxib Is Indicated For The Relief Of Signs And Symptoms Of As [see Clinical Studies (14.4)] 1.5 Acute Pain (ap) Celecoxib Is Indicated For The Management Of Ap In Adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea (pd) Celecoxib Is Indicated For The Treatment Of Pd [see Clinical Studies (14.5)]

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Povidones POVIDONES Unresolved
4. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Celecoxib CELECOXIB ZINC2570895

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