APPLICATION
ANDA219386
TYPE
ANDA
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
SUVOREXANTNone (Tentative Approval)
SUVOREXANT 20MG · TABLET
SUVOREXANTNone (Tentative Approval)
SUVOREXANT 10MG · TABLET
SUVOREXANTNone (Tentative Approval)
SUVOREXANT 15MG · TABLET
SUVOREXANTNone (Tentative Approval)
SUVOREXANT 5MG · TABLET
Approval history
2025-12-22UNKNOWN · 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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