APPLICATION
ANDA202118
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-21
LATEST ACTION
2023-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Discontinued
Products
DARUNAVIRNone (Tentative Approval)
DARUNAVIR 400MG · TABLET · ORAL
DARUNAVIRDiscontinued
DARUNAVIR 600MG · TABLET · ORAL
DARUNAVIRNone (Tentative Approval)
DARUNAVIR 600MG · TABLET · ORAL
DARUNAVIRNone (Tentative Approval)
DARUNAVIR 150MG · TABLET · ORAL
Approval history
2023-12-21Labeling · Supplement 5 · standardAP
2023-12-21Labeling · Supplement 3 · standardAP
2017-11-21Not Applicable · OriginalTA
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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