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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078945
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
01/03/2013 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
08/18/2021 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

08/18/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/14/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/14/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/14/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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