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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077009
Company: TARO

Products on ANDA 077009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2007	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
04/23/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/30/2017	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/20/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/20/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/27/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/29/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077009

ONDANSETRON HYDROCHLORIDE

SOLUTION;ORAL; EQ 4MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	091483	AMNEAL PHARMS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	078776	AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	091342	CHARTWELL MOLECULAR
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	076960	HIKMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	077009	TARO

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