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 Carefully Consider The Potential Benefits And Risks Of Celecoxib Capsules And Other Treatment Options Before Deciding To Use Celecoxib Capsules. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals [ See Warnings And Precautions ( 5 )]. 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) Celecoxib Capsules Are Indicated For Relief Of The Signs And Symptoms Of Oa [ See Clinical Studies ( 14.1 )]. 1.2 Rheumatoid Arthritis (ra) Celecoxib Capsules Are Indicated For Relief Of The Signs And Symptoms Of Ra [ See Clinical Studies ( 14.2 )]. 1.3 Juvenile Rheumatoid Arthritis (jra) Celecoxib Capsules Are 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 Capsules Are Indicated For The Relief Of Signs And Symptoms Of As [ See Clinical Studies ( 14.4 )]. 1.5 Acute Pain (ap) Celecoxib Capsules Are Indicated For The Management Of Ap In Adults [ See Clinical Studies ( 14.5 )]. 1.6 Primary Dysmenorrhea (pd) Celecoxib Capsules Are Indicated For The Treatment Of Pd [ 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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