Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076960
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription AA 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
12/26/2006 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
05/14/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/14/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/02/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/17/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/13/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ONDANSETRON HYDROCHLORIDE

SOLUTION;ORAL; EQ 4MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription No AA 091483 AMNEAL PHARMS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription No AA 078776 AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription No AA 076960 HIKMA
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription No AA 091342 LANNETT CO INC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription No AA 078127 PHARM ASSOC
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription No AA 077009 TARO
ZOFRAN ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML SOLUTION;ORAL Prescription Yes AA 020605 NOVARTIS

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