Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212290
Company: MYLAN PHARMS INC

Products on ANDA 212290

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALIPERIDONE PALMITATE	PALIPERIDONE PALMITATE	546MG/1.75ML	INJECTABLE; SUSPENSION, EXTENDED RELEASE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212290

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2024	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212290Orig1s000TA_ltr.pdf