APPLICATION
ANDA204621
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-10
LATEST ACTION
2022-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NEVIRAPINEDiscontinued
NEVIRAPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
NEVIRAPINEDiscontinued
NEVIRAPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-12-13Labeling · Supplement 6 · standardAP
2019-08-14Labeling · Supplement 4 · standardAP
2019-08-14Labeling · Supplement 5 · standardAP
2015-09-11UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.