Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077343
Company: APOTEX INC

Products on ANDA 077343

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077343

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2006	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
03/15/2022	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/16/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/16/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/31/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/31/2014	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
12/31/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/19/2007	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
06/14/2007	SUPPL-1	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.