Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 077551
Company: SANDOZ

Products on ANDA 077551

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	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077551

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
01/20/2015	SUPPL-7	Labeling-Package Insert	Label is not available on this site.
01/20/2015	SUPPL-6	Labeling-Package Insert	Label is not available on this site.
04/08/2013	SUPPL-5	Labeling-Package Insert	Label is not available on this site.
04/08/2013	SUPPL-3	Labeling-Package Insert	Label is not available on this site.

Therapeutic Equivalents for ANDA 077551

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206846	ACCORD HLTHCARE
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076974	FRESENIUS KABI USA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	079224	GLAND PHARMA LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090648	GLAND PHARMA LTD
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076967	HIKMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077365	HIKMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076781	HIKMA FARMACEUTICA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077473	HOSPIRA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203711	QILU PHARM HAINAN
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077430	SANDOZ
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077577	WOCKHARDT
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206845	ACCORD HLTHCARE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	078287	BAXTER HLTHCARE CORP
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076972	FRESENIUS KABI USA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	202253	FRESENIUS KABI USA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077011	HIKMA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077541	HIKMA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077548	HOSPIRA
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077551	SANDOZ
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	077716	WOCKHARDT