U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091136
Company: MYLAN ASI

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No

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-9 Labeling-Package Insert

Label is not available on this site.
09/18/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
09/15/2014 SUPPL-7 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-3 Labeling-Container/Carton Labels

Label is not available on this site.
04/18/2012 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 0.1MG BASE/ML (EQ 0.1MG 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 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078262 AMNEAL
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078863 BIONPHARMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078392 DR REDDYS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078522 FRESENIUS KABI USA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077913 HIKMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 091136 MYLAN ASI
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078534 SANDOZ

INJECTABLE;INJECTION; EQ 1MG BASE/ML (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 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078258 AMNEAL
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077187 HIKMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078629 HIKMA FARMACEUTICA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 091136 MYLAN ASI
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 079078 RISING
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078531 SANDOZ
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078835 SANDOZ INC
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078863 BIONPHARMA
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078096 FRESENIUS KABI USA
Back to Top