An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091137
Company: MYLAN ASI

Products on ANDA 091137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	1MG/ML	INJECTABLE; INJECTION	Prescription	None	No	No
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 091137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2010	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
11/08/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/18/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/15/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/06/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/06/2013	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
04/18/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/01/2011	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091137

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

Top