Application Nr Approved Date Route Status External Links
NDA212379 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Amzeeq Is Indicated For The Topical Treatment Of Inflammatory Lesions Of Non-Nodular Moderate To Severe Acne Vulgaris In Adults And Pediatric Patients 9 Years Of Age And Older [ See Clinical Studies ( 14 ) ]. Limitations Of Use This Formulation Of Minocycline Has Not Been Evaluated In The Treatment Of Infections. To Reduce The Development Of Drug-Resistant Bacteria As Well As To Maintain The Effectiveness Of Other Antibacterial Drugs, Amzeeq Should Be Used Only As Indicated [ See Warnings And Precautions ( 5.14 ) ]. Amzeeq Is A Tetracycline-Class Drug Indicated To Treat Inflammatory Lesions Of Non-Nodular Moderate To Severe Acne Vulgaris In Patients 9 Years Of Age And Older. ( 1 ) Limitations Of Use This Formulation Of Minocycline Has Not Been Evaluated In The Treatment Of Infections. To Reduce The Development Of Drug-Resistant Bacteria As Well As To Maintain The Effectiveness Of Other Antibacterial Drugs, Amzeeq Should Be Used Only As Indicated. ( 5.14 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE ZINC14879992

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