Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020726
Company: NOVARTIS PHARMS
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 |
|---|---|---|---|---|---|
| 04/05/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020726s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020726Orig1s035ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/05/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020726s035lbl.pdf | |
| 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 | 205869 | BEIJING YILING |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 091191 | CARNEGIE |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211717 | EUGIA PHARMA |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 200161 | NATCO PHARMA LTD |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090289 | TEVA PHARMS |