Application Nr Approved Date Route Status External Links
ANDA078195 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nevirapine Tablets, Usp Are An Nnrti 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. (1) Limitations Of Use: Based On Serious And Life-Threatening Hepatotoxicity Observed In Controlled And Uncontrolled Trials, Nevirapine Tablets, Usp Is Not Recommended To Be Initiated, Unless The Benefit Outweighs The Risk, In: Adult Females With Cd4 + Cell Counts Greater Than 250 Cells/mm 3 Adult Males With Cd4 + Cell Counts Greater Than 400 Cells/mm 3. (1, 5.1) Nevirapine Tablets, Usp 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 Tablets, Usp Is Not Recommended To Be Initiated, Unless The Benefit Outweighs The Risk, In: Adult Females With Cd4 + Cell Counts Greater Than 250 Cells/mm 3 Or Adult Males With Cd4 + Cell Counts Greater Than 400 Cells/mm 3 [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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