Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078846
Company: DR REDDYS LABS LTD

Products on ANDA 078846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2009	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
07/20/2023	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/20/2023	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
09/18/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/23/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078846

GRANISETRON HYDROCHLORIDE

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	078037	CHARTWELL MOLECULAR
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	078846	DR REDDYS LABS LTD
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	078969	NATCO PHARMA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	078678	ORBION PHARMS