Application Nr Approved Date Route Status External Links
ANDA091640 2017-06-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Mesalamine Delayed-Release Tablets Are Locally Acting 5-Aminosalicylic Acid (5-Asa) Indicated For The Induction Of Remission In Adults With Active, Mild To Moderate Ulcerative Colitis And For The Maintenance Of Remission Of Ulcerative Colitis. (1) Mesalamine Delayed-Release Tablets Are Indicated For The Induction Of Remission In Patients With Active, Mild To Moderate Ulcerative Colitis And For The Maintenance Of Remission Of Ulcerative Colitis.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Carboxymethylcellulose Sodium, Unspecified Form CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
6. 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.
7. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Mesalamine MESALAMINE ZINC1688

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