Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078583
Company: APOTEX

Products on ANDA 078583

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET;ORAL	Discontinued	None	No	No
ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET;ORAL	Discontinued	None	No	No
ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET;ORAL	Discontinued	None	No	No
ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET;ORAL	Discontinued	None	No	No
ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET;ORAL	Discontinued	None	No	No
ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2015	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
12/16/2022	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
12/16/2022	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/16/2022	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/16/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/16/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/16/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/16/2022	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.