Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078187
Company: SYNTHON PHARMS

Products on ANDA 078187

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISPERIDONE	RISPERIDONE	0.25MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	0.5MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	1MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	2MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	3MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078187

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2009	ORIG-1	Approval				Label is not available on this site.