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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077544
Company: PLIVA HRVATSKA DOO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE 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
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
06/07/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/07/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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