Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077963
Company: TEVA PHARMS USA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/03/2008 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
09/18/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf
05/30/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/11/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077963s010lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf
04/11/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077963s010lbl.pdf

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