Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079078
Company: AKORN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (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
09/14/2009 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
09/01/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/18/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/31/2011 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

GRANISETRON HYDROCHLORIDE

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 079078 AKORN INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 204238 AUROBINDO PHARMA LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078258 CIPLA LTD
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 203454 MYLAN LABS LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078531 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078835 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077187 WEST-WARD PHARMS INT
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078564 WOCKHARDT USA
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078863 BIONPHARMA INC
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078096 FRESENIUS KABI USA

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 079078 AKORN INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 204238 AUROBINDO PHARMA LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078880 BIONPHARMA INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078258 CIPLA LTD
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 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 203453 MYLAN LABS LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078531 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078835 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077177 WEST-WARD PHARMS INT
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077186 WEST-WARD PHARMS INT
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078565 WOCKHARDT USA

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