APPLICATION
ANDA211995
TYPE
ANDA
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 234MG/1.5ML · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 117MG/0.75ML · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 39MG/0.25ML · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 156MG/ML · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 78MG/0.5ML · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
Approval history
2023-06-30UNKNOWN · 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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