APPLICATION
ANDA206448
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-15
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NEVIRAPINEDiscontinued
NEVIRAPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-07-01Labeling · Supplement 7 · standardAP
2023-11-29Labeling · Supplement 6 · standardAP
2019-08-14Labeling · Supplement 5 · standardAP
2019-08-14Labeling · Supplement 3 · standardAP
2019-08-14Labeling · Supplement 1 · standardAP
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.
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