Application Nr Approved Date Route Status External Links
ANDA202413 2016-11-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Ibuprofen Tablets And Other Treatment Options Before Deciding To Use Ibuprofen. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings ). Ibuprofen Tablets Are Indicated For Relief Of The Signs And Symptoms Of Rheumatoid Arthritis And Osteoarthritis. Ibuprofen Tablets Are Indicated For Relief Of Mild To Moderate Pain. Ibuprofen Tablets Are Also Indicated For The Treatment Of Primary Dysmenorrhea. Controlled Clinical Trials To Establish The Safety And Effectiveness Of Ibuprofen Tablets In Children Have Not Been Conducted.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ibuprofen IBUPROFEN ZINC2647

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