Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076440
Company: ANI PHARMS

• Other Important Information from FDA

Products on ANDA 076440

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076440

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/14/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/14/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/11/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/27/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076440

RISPERIDONE

SOLUTION;ORAL; 1MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISPERDAL	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	020588	JANSSEN PHARMS
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	091384	AMNEAL PHARMS
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	076440	ANI PHARMS
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	078909	APOZEAL PHARMS
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	078452	AUROBINDO PHARMA LTD
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	202386	CHARTWELL MOLECULAR
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	079059	TRIS PHARMA INC