APPLICATION
ANDA203411
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-03
LATEST ACTION
2025-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NEVIRAPINEPrescription
NEVIRAPINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-02-27Labeling · Supplement 9 · standardAP
2022-11-25Labeling · Supplement 8 · standardAP
2019-08-29Labeling · Supplement 4 · standardAP
2019-08-29Labeling · Supplement 5 · 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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