Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021654
Company: SMITHKLINE BEECHAM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOVAZA OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;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
11/10/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21654ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-654_Omacor.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2019 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021654s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021654Orig1s043ltr.pdf
03/09/2015 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

05/14/2014 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021654s041ltr.pdf
06/05/2014 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/11/2013 SUPPL-39 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf
11/15/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/26/2013 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021654Orig1s037ltr.pdf
08/31/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021654s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021654Orig1s034ltr.pdf
09/19/2011 SUPPL-33 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021654s033ltr.pdf
08/11/2011 SUPPL-31 Labeling

Label is not available on this site.

12/22/2010 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021654s030ltr.pdf
04/20/2009 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s023ltr.pdf
09/16/2009 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021654s022ltr.pdf
06/03/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021654s021ltr.pdf
01/24/2008 SUPPL-18 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021654Orig1s018.pdf
06/12/2007 SUPPL-16 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm
12/06/2007 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s015ltr.pdf
11/07/2007 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s014ltr.pdf
07/03/2006 SUPPL-7 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021654s007LTR.pdf
02/01/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021654s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2019 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021654s043lbl.pdf
05/14/2014 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf
09/11/2013 SUPPL-39 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s039lbl.pdf
06/26/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021654s037lbl.pdf
08/31/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021654s034lbl.pdf
12/22/2010 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021654s030lbl.pdf
09/16/2009 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s022lbl.pdf
04/20/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021654s023lbl.pdf
06/03/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021654s021lblR.pdf
02/01/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021654s004lbl.pdf
11/10/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21654lbl.pdf

LOVAZA

CAPSULE;ORAL; 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOVAZA OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription Yes AB 021654 SMITHKLINE BEECHAM
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 204940 AMNEAL PHARMS
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 090973 APOTEX INC
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 207420 ASCENT PHARMS INC
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 211355 SOFGEN PHARMS
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 203893 STRIDES PHARMA
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 091028 TEVA PHARMS USA
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 210107 ZYDUS

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