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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077297
Company: DR REDDYS

Products on ANDA 077297

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf
05/30/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/30/2013	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/13/2012	SUPPL-10	Labeling-Package Insert	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077297Orig1s010.pdf

Labels for ANDA 077297

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf
04/13/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf

Therapeutic Equivalents for ANDA 077297

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078258	AMNEAL
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078880	BIONPHARMA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077297	DR REDDYS
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078090	FRESENIUS KABI USA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077177	HIKMA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077186	HIKMA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078629	HIKMA FARMACEUTICA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091137	MYLAN ASI
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	079078	RISING
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078531	SANDOZ
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078835	SANDOZ INC

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