Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076904
Company: HIKMA

Products on ANDA 076904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2009	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
09/22/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/15/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/09/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/09/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/07/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/25/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/11/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.