Application Nr Approved Date Route Status External Links
ANDA073580 1995-01-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Mebendazole Tablets Are Indicated For The Treatment Of Enterobius Vermicularis (pinworm), Trichuris Trichiura (whipworm), Ascaris Lumbricoides (common Roundworm), Ancylostoma Duodenale (common Hookworm), Necator Americanus (american Hookworm) In Single Or Mixed Infections. Efficacy Varies As A Function Of Such Factors As Preexisting Diarrhea And Gastrointestinal Transit Time, Degree Of Infection, And Helminth Strains. Efficacy Rates Derived From Various Studies Are Shown In The Table Below: Pinworm (enterobiasis) Whipworm (trichuriasis) Common Roundworm (ascariasis) Hookworm Cure Rates Mean 95% 68% 98% 96% Egg Reduction Mean — 93% 99% 99%

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. 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.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. 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.
5. Saccharin Sodium SACCHARIN SODIUM Molecular
6. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Mebendazole MEBENDAZOLE ZINC121541

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