Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078452
Company: AUROBINDO PHARMA LTD

Products on ANDA 078452

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 078452

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2009	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
08/08/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/09/2023	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/13/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/13/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/13/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/13/2020	SUPPL-7	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/13/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/23/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/22/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/30/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/10/2011	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/19/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078452

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	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	079158	LANNETT CO INC
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	090347	TARO
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	079059	TRIS PHARMA INC