APPLICATION
ANDA077521
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-22
LATEST ACTION
2023-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NEVIRAPINEPrescription
NEVIRAPINE 200MG · TABLET · ORAL
Approval history
2023-03-31Labeling · Supplement 22 · standardAP
2019-12-10Labeling · Supplement 18 · standardAP
2019-12-10Labeling · Supplement 20 · standardAP
2015-01-20Labeling · Supplement 16 · standardAP
2015-01-20Labeling · Supplement 15 · standardAP
2013-02-01Labeling · Supplement 12 · 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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