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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076228
Company: HERITAGE PHARMA AVET

Other Important Information from FDA

Products on ANDA 076228

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 076228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2008	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076228s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/04/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/04/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/10/2011	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/20/2011	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/15/2011	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/29/2010	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/26/2010	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/23/2009	SUPPL-2	Labeling		Label is not available on this site.
11/19/2008	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 076228

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf

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