APPLICATION
ANDA216674
TYPE
ANDA
ROUTE
SUSPENSION, EXTENDED RELEASE
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)
Products
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 39MG · INJECTABLE · SUSPENSION, EXTENDED RELEASE
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 117MG · INJECTABLE · SUSPENSION, EXTENDED RELEASE
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 78MG · INJECTABLE · SUSPENSION, EXTENDED RELEASE
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 156MG · INJECTABLE · SUSPENSION, EXTENDED RELEASE
Approval history
2025-05-16UNKNOWN · 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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