Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078198
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Discontinued None No No
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG 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
06/30/2008 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
09/26/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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