Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091483
Company: AMNEAL PHARMS
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
01/31/2011 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/07/2018 SUPPL-5 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

02/07/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/07/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/27/2012 SUPPL-2 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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