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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078516
Company: ZYDUS PHARMS USA

Products on ANDA 078516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2009	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
11/26/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/02/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/16/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/30/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/25/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/11/2011	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/10/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/29/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/06/2009	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 078516

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077328	DR REDDYS LABS LTD
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090839	JUBILANT GENERICS
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077494	PAR PHARM
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078116	SANDOZ
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077542	SUN PHARM INDS LTD
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078464	SUN PHARM INDS LTD
RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078516	ZYDUS PHARMS USA

TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077328	DR REDDYS LABS LTD
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090839	JUBILANT GENERICS
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077494	PAR PHARM
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078116	SANDOZ
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	077542	SUN PHARM INDS LTD
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078464	SUN PHARM INDS LTD
RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	078516	ZYDUS PHARMS USA

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