Application Nr Approved Date Route Status External Links
ANDA076898 2014-05-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Celecoxib Capsules Are Indicated Celecoxib Capsules Are 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) 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 (7 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
3. Povidones POVIDONES Unresolved
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Shellac SHELLAC Unresolved
6. 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.
7. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer 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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