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FDA ANDA · ANDA215682
PALIPERIDONE PALMITATE
Sponsor: MYLAN PHARMACEUTICALS INC A VIATRIS CO
APPLICATION
ANDA215682
TYPE
ANDA
ROUTE
SUSPENSION
DOSAGE FORM
INJECTION
MARKETING STATUS
None (Tentative Approval)
Products
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 1560MG/5.0ML · INJECTION · SUSPENSION
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 819MG/2.625ML · INJECTION · SUSPENSION
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 410MG/1.315ML · INJECTION · SUSPENSION
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 1092MG/3.5ML · INJECTION · SUSPENSION
PALIPERIDONE PALMITATENone (Tentative Approval)
PALIPERIDONE PALMITATE 546MG/1.75ML · INJECTION · SUSPENSION
Approval history
2024-12-03UNKNOWN · 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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