Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077545
Company: HIKMA INTL PHARMS

Products on ANDA 077545

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Discontinued	None	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Discontinued	None	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077545

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2007	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
05/15/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/15/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/21/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/21/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/15/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/11/2008	SUPPL-2	Labeling		Label is not available on this site.