Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215682
Company: MYLAN PHARMACEUTICALS INC A VIATRIS CO

Products on ANDA 215682

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	273MG/0.875ML	INJECTION;SUSPENSION	None (Tentative Approval)	None	No	No
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	410MG/1.315ML	INJECTION;SUSPENSION	None (Tentative Approval)	None	No	No
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	546MG/1.75ML	INJECTION;SUSPENSION	None (Tentative Approval)	None	No	No
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	819MG/2.625ML	INJECTION;SUSPENSION	None (Tentative Approval)	None	No	No
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	1092MG/3.5ML	INJECTION;SUSPENSION	None (Tentative Approval)	None	No	No
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	1560MG/5.0ML	INJECTION;SUSPENSION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215682

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2024	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.