Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078539
Company: AUROBINDO PHARMA

Products on ANDA 078539

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	AB	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 078539

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2007	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
03/07/2018	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/07/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/15/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/15/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/17/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/04/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078539

ONDANSETRON HYDROCHLORIDE

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077306	APOTEX
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	078539	AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077303	CHARTWELL MOLECULES
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	076183	DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077535	GLENMARK PHARMS LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	203761	IPCA LABS LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077851	NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077050	SUN PHARM INDS (IN)

TABLET;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077306	APOTEX
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	078539	AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077303	CHARTWELL MOLECULES
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	076183	DR REDDYS LABS LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077535	GLENMARK PHARMS LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	203761	IPCA LABS LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077851	NATCO PHARMA LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077050	SUN PHARM INDS (IN)