Application Nr Approved Date Route Status External Links
ANDA200173 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Imiquimod Cream Usp, 5% Is Indicated For The Topical Treatment Of: Clinically Typical, Nonhyperkeratotic, Nonhypertrophic Actinic Keratoses (Ak) On The Face Or Scalp In Immunocompetent Adults ( 1.1 ) External Genital And Perianal Warts/condyloma Acuminata In Patients 12 Years Old Or Older ( 1.3 ) Limitations Of Use: Efficacy Was Not Demonstrated For Molluscum Contagiosum In Children Aged 2-12 ( 1.4 , 8.4 ) 1.1 Actinic Keratosis Imiquimod Cream Usp, 5% Is Indicated For The Topical Treatment Of Clinically Typical, Nonhyperkeratotic, Nonhypertrophic Actinic Keratoses On The Face Or Scalp In Immunocompetent Adults. 1.3 External Genital Warts Imiquimod Cream Usp, 5% Is Indicated For The Treatment Of External Genital And Perianal Warts/condyloma Acuminata In Patients 12 Years Or Older. 1.4 Limitations Of Use Imiquimod Cream Usp, 5% Has Been Evaluated In Children Ages 2 To 12 Years With Molluscum Contagiosum And These Studies Failed To Demonstrate Efficacy [See Use In Specific Populations (8.4) ]. 1.5 Unevaluated Populations The Safety And Efficacy Of Imiquimod Cream Usp, 5% In Immunosuppressed Patients Have Not Been Established. Imiquimod Cream Should Be Used With Caution In Patients With Pre-Existing Autoimmune Conditions. The Efficacy And Safety Of Imiquimod Cream Have Not Been Established For Patients With Basal Cell Nevus Syndrome Or Xeroderma Pigmentosum.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Imiquimod IMIQUIMOD ZINC19632912

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