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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090648
Company: GLAND PHARMA LTD

Products on ANDA 090648

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090648Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/11/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/18/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/18/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/09/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/09/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/30/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/30/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090648

ONDANSETRON HYDROCHLORIDE

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	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 BIO AG
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 BIO AG

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