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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078474
Company: SUN PHARM INDS LTD

Products on ANDA 078474

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No
RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078474

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2010	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
01/22/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/28/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/28/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/29/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/27/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/21/2012	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078474

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090839	JUBILANT GENERICS
RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077494	PH HEALTH
RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078116	SANDOZ
RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077328	SENORES PHARMS
RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078474	SUN PHARM INDS LTD

TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090839	JUBILANT GENERICS
RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077494	PH HEALTH
RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078116	SANDOZ
RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077328	SENORES PHARMS
RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078474	SUN PHARM INDS LTD

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