Application Nr Approved Date Route Status External Links
ANDA074473 1994-08-30 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 Tolmetin Sodium Tablets, Usp And Other Treatment Options Before Deciding To Use Tolmetin Sodium Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Tolmetin Sodium Tablets Are Indicated For The Relief Of Signs And Symptoms Of Rheumatoid Arthritis And Osteoarthritis. Tolmetin Sodium Tablets Are Indicated In The Treatment Of Acute Flares And The Long-Term Management Of The Chronic Disease. Tolmetin Sodium Tablets Are Also Indicated For Treatment Of Juvenile Rheumatoid Arthritis. The Safety And Effectiveness Of Tolmetin Sodium Tablets Have Not Been Established In Pediatric Patients Under 2 Years Of Age (see Precautions: Pediatric Use And Dosage And Administration).

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Povidones POVIDONES Unresolved
8. 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.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tolmetin Sodium TOLMETIN SODIUM ZINC2191

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