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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077303
Company: CHARTWELL MOLECULES

Products on ANDA 077303

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	16MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077303

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2007	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
02/26/2018	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/23/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077303

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	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

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	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

TABLET;ORAL; EQ 24MG 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 24MG BASE	TABLET;ORAL	Prescription	No	AB	077303	CHARTWELL MOLECULES

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