APPLICATION
ANDA215464
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
IBRUTINIBNone (Tentative Approval)
IBRUTINIB 560MG · TABLET · ORAL
IBRUTINIBNone (Tentative Approval)
IBRUTINIB 280MG · TABLET · ORAL
IBRUTINIBNone (Tentative Approval)
IBRUTINIB 420MG · TABLET · ORAL
IBRUTINIBNone (Tentative Approval)
IBRUTINIB 140MG · TABLET · ORAL
Approval history
2023-02-10UNKNOWN · 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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