Application Nr Approved Date Route Status External Links
NDA050813 2008-01-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Moxatag Is A Penicillin-Class Antibacterial Indicated For The Treatment Of Tonsillitis And/or Pharyngitis Secondary To Streptococcus Pyogenes In Adults And Pediatric Patients 12 Years And Older. (1) Tonsillitis And/or Pharyngitis Moxatag Is A Penicillin-Class Antibacterial Indicated For The Treatment Of Tonsillitis And/or Pharyngitis Secondary To Streptococcus Pyogenes (s. Pyogenes) In Adults And Pediatric Patients 12 Years And Older. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Moxatag And Other Antibacterial Drugs, Moxatag Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (14 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Hypromellose Acetate Succinate HYPROMELLOSE ACETATE SUCCINATE Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. 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.
5. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
8. Polyoxyl 35 Castor Oil POLYOXYL 35 CASTOR OIL Unresolved
9. Povidones POVIDONES Unresolved
10. Shellac SHELLAC Unresolved
11. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
12. 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.
13. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
14. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amoxicillin AMOXICILLIN ZINC3830215

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