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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076183
Company: DR REDDYS LABS LTD

Products on ANDA 076183

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET;ORAL	Discontinued	None	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	AB	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076183s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2023	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/04/2023	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/26/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/26/2018	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/26/2018	SUPPL-7	Labeling-Container/Carton Labels, 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.
12/20/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/13/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/30/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076183

ONDANSETRON HYDROCHLORIDE

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	077306	APOTEX
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
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	077050	SUN PHARM INDS (IN)

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	077306	APOTEX
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
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	077050	SUN PHARM INDS (IN)

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