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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091342
Company: LANNETT CO INC
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
01/27/2011 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
01/27/2011 SUPPL-27

Label is not available on this site.

06/23/2022 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/14/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/14/2018 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/03/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/14/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/13/2011 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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