APPLICATION
ANDA206288
TYPE
ANDA
ORIGINAL APPROVAL
2023-11-28
LATEST ACTION
2023-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription
Products
DARUNAVIRNone (Tentative Approval)
DARUNAVIR 800MG · TABLET · ORAL
DARUNAVIRNone (Tentative Approval)
DARUNAVIR 400MG · TABLET · ORAL
DARUNAVIRPrescription
DARUNAVIR 600MG · TABLET · ORAL
DARUNAVIRNone (Tentative Approval)
DARUNAVIR 600MG · TABLET · ORAL
DARUNAVIRPrescription
DARUNAVIR 800MG · TABLET · ORAL
Approval history
2023-11-28UNKNOWN · Original · standardTA
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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