Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078392
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/31/2007 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-17 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-14 Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/13/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078392s011lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf
04/13/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078392s011lbl.pdf

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 079119 AKORN INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078863 BIONPHARMA INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078262 CIPLA LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078522 FRESENIUS KABI USA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 091136 MYLAN ASI
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203454 MYLAN LABS LTD
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078534 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078392 TEVA PHARMS USA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077913 WEST-WARD PHARMS INT
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078566 WOCKHARDT USA

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