Application Nr Approved Date Route Status External Links
ANDA078644 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nevirapine Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Human Immunodeficiency Virus (Hiv-1) Infection In Adults And Pediatric Patients 15 Days And Older. [See Clinical Studies ( 14.1 , 14.2 )] Limitations Of Use: Based On Serious And Life-Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Is Not Recommended To Be Initiated, Unless The Benefit Outweighs The Risk, In: • Adult Females With Cd4+ Cell Counts Greater Than 250 Cells/mm3 • Adult Males With Cd4+ Cell Counts Greater Than 400 Cells/mm3. [See Warnings And Precautions ( 5.1 )] Nevirapine Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Human Immunodeficiency Virus (Hiv-1) Infection In Adults And Pediatric Patients 15 Days And Older. [See Clinical Studies( 14.1 , 14.2 ).] Limitations Of Use: Based On Serious And Life-Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Is Not Recommended To Be Initiated, Unless The Benefit Outweighs The Risk, In: • Adult Females With Cd4+ Cell Counts Greater Than 250 Cells/mm3 • Adult Males With Cd4+ Cell Counts Greater Than 400 Cells/mm3. [See Warnings And Precautions ( 5.1 )]

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nevirapine NEVIRAPINE ZINC4778

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