Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020509
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMZAR GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
GEMZAR GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes 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
05/15/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2018 SUPPL-80 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf
09/13/2017 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020509s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020509Orig1s079ltr.pdf
05/08/2014 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s077ltr.pdf
08/11/2014 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

06/10/2014 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020509Orig1s075ltr.pdf
05/07/2013 SUPPL-72 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020509s072lbl.pdf
02/04/2011 SUPPL-69 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf
03/19/2010 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020509s064ltr.pdf
07/14/2006 SUPPL-39 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s039_ltr.pdf
04/05/2006 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020509s037ltr.pdf
04/26/2005 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020509_S033_GEMZAR.pdf
04/20/2005 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020509s032ltr.pdf
05/19/2004 SUPPL-29 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20509se1-029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020509_S029_GEMZAR_AP.pdf
11/13/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2002 SUPPL-21 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20509s021ltr.pdf
05/18/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/2003 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20509slr013ltr.pdf
11/23/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/23/2000 SUPPL-10 Labeling

Label is not available on this site.

10/16/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/25/1998 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20509lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20509ltr.pdf
09/18/1997 SUPPL-4 Labeling

Label is not available on this site.

10/10/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/11/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/08/2018 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf
06/08/2018 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020509s080lbl.pdf
09/13/2017 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020509s079lbl.pdf
06/10/2014 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s075lbl.pdf
05/08/2014 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020509s077lbl.pdf
05/07/2013 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020509s072lbl.pdf
02/04/2011 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf
02/04/2011 SUPPL-69 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020509s069lbl.pdf
03/19/2010 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020509s064lbl.pdf
04/26/2005 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s033lbl.pdf
04/20/2005 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020509s032lbl.pdf
05/19/2004 SUPPL-29 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020509s029lbl.pdf
01/06/2003 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020509s013lbl.pdf
08/25/1998 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20509lbl.pdf

GEMZAR

INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091594 ACCORD HLTHCARE
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 079160 ACTAVIS TOTOWA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078759 CIPLA LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091365 DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202063 EMCURE PHARMS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090799 FRESENIUS KABI ONCOL
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204520 GLAND PHARMA LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078339 HOSPIRA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202485 JIANGSU HANSOH PHARM
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202031 LUITPOLD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200145 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078433 SUN PHARMA GLOBAL
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 077983 TEVA PHARMS
GEMZAR GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020509 LILLY

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091594 ACCORD HLTHCARE
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 079160 ACTAVIS TOTOWA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078759 CIPLA LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091365 DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202063 EMCURE PHARMS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090799 FRESENIUS KABI ONCOL
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204520 GLAND PHARMA LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078339 HOSPIRA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202485 JIANGSU HANSOH PHARM
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202031 LUITPOLD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200145 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078433 SUN PHARMA GLOBAL
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 077983 TEVA PHARMS
GEMZAR GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020509 LILLY

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