Application Nr Approved Date Route Status External Links
ANDA075665 2001-02-05 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 Etodolac Extended-Release Tablets And Other Treatment Options Before Deciding To Use Etodolac Extended-Release Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Etodolac Extended-Release Tablets Are Indicated: * For Relief Of Signs And Symptoms Of Juvenile Arthritis * For Relief Of The Signs And Symptoms Of Rheumatoid Arthritis * For Relief Of The Signs And Symptoms Of Osteoarthritis

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Etodolac ETODOLAC ZINC3642

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