Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020726
Company: NOVARTIS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FEMARA LETROZOLE 2.5MG TABLET;ORAL Prescription AB 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
07/25/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020726_femara_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020726s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020726Orig1s033ltr.pdf
10/28/2016 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/23/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020726Orig1s027ltr.pdf
07/11/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/23/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020726s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020726s024ltr.pdf
04/30/2010 SUPPL-20 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s020ltr.pdf
06/25/2010 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s019ltr.pdf
07/07/2009 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020726s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020726s018ltr.pdf
08/07/2008 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020726s017ltr.pdf
03/02/2010 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf
03/02/2010 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf
04/11/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020726s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020726s014LTR.pdf
06/26/2006 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020726s013LTR.pdf
12/28/2005 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020726s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020726s012rev2.pdf
10/29/2004 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020726s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20726s011ltr.pdf
01/17/2003 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726s8ltr.pdf
01/10/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/10/2001 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20726S006LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20726S006LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-726S006_Femara.cfm
02/26/2003 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726se8-005ltr.pdf
05/23/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/05/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/17/1999 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
07/13/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020726s033lbl.pdf
01/15/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf
12/23/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020726s024lbl.pdf
06/25/2010 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s019lbl.pdf
04/30/2010 SUPPL-20 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s020lbl.pdf
03/02/2010 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf
03/02/2010 SUPPL-15 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf
07/07/2009 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020726s018lbl.pdf
04/11/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020726s014lbl.pdf
12/28/2005 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020726s012lbl.pdf
10/29/2004 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020726s011lbl.pdf
02/26/2003 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s005lbl.pdf
01/17/2003 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s008lbl.pdf
01/10/2001 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20726S006LBL.PDF

FEMARA

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEMARA LETROZOLE 2.5MG TABLET;ORAL Prescription Yes AB 020726 NOVARTIS PHARMS
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090934 ACCORD HLTHCARE
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 091303 APOTEX INC
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 091191 DR REDDYS LABS LTD
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090491 FRESENIUS KABI ONCOL
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 203796 HIKMA PHARMS
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 201804 INDICUS PHARMA
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 202716 JIANGSU HENGRUI MED
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 078190 MYLAN
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 200161 NATCO PHARMA LTD
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 091466 SUN PHARM INDS LTD
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090289 TEVA PHARMS
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090789 VINTAGE PHARMS LLC
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090838 WEST-WARD PHARMS INT

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