Application Nr Approved Date Route Status External Links
ANDA202240 2015-06-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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)]

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Gelatin GELATIN Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Povidones POVIDONES Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Shellac SHELLAC Unresolved
9. 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.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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