Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077177
Company: HIKMA

Products on ANDA 077177

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077177

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2007	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
08/19/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/18/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077177

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