APPLICATION
ANDA208616
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-23
LATEST ACTION
2022-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NEVIRAPINEDiscontinued
NEVIRAPINE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-11-28Labeling · Supplement 6 · standardAP
2019-08-21Labeling · Supplement 4 · standardAP
2019-08-21Labeling · Supplement 2 · standardAP
2016-11-23UNKNOWN · Original · 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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