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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091483
Company: AMNEAL PHARMS

Products on ANDA 091483

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 091483

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2011	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
06/14/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/01/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/07/2018	SUPPL-5	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
02/07/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/07/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/27/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091483

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	078127	PHARM ASSOC

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