FDA.reportPublic FDA data

Application 021654

Type
NDA
Sponsor
SMITHKLINE BEECHAM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOVAZAOMEGA-3-ACID ETHYL ESTERSCAPSULE;ORAL1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0783LOVAZAomega-3-acid ethyl estersGlaxoSmithKline LLCNDACurrent
0173-0783LOVAZAomega-3-acid ethyl estersGlaxoSmithKline LLCNDACurrent
0173-0884LOVAZAomega-3-acid ethyl estersGlaxoSmithKline LLCNDACurrent
0173-0884LOVAZAomega-3-acid ethyl estersGlaxoSmithKline LLCNDACurrent
0173-0884LOVAZAomega-3-acid ethyl estersGlaxoSmithKline LLCNDACurrent
17856-0084LOVAZAomega-3-acid ethyl estersAtlantic Biologicals CorpsNDACurrent
17856-0783LOVAZAomega-3-acid ethyl estersAtlantic Biologicals CorpsNDACurrent
21695-795LOVAZAomega-3-acid ethyl estersRebel Distributors CorpNDACurrent
66993-726Omega-3-acid ethyl estersomega-3-acid ethyl estersPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-839Omega-3-acid ethyl estersomega-3-acid ethyl estersPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64525SUPPL2020-09-08
64524SUPPL2020-09-08
58311SUPPL2019-04-12
58209SUPPL2019-04-04
15929SUPPL2014-05-14
5928SUPPL2014-05-14
15928SUPPL2013-09-17
37407SUPPL2013-07-08
5927SUPPL2013-06-27
37406SUPPL2012-09-06
28319SUPPL2012-09-06
42254SUPPL2011-12-14
5926SUPPL2011-09-21
5925SUPPL2010-12-28
15927SUPPL2010-12-26
21768SUPPL2009-11-19
5924SUPPL2009-11-10
15926SUPPL2009-09-21
37405SUPPL2009-04-23
28318SUPPL2009-04-21
15925SUPPL2008-06-19
5923SUPPL2008-06-06
28317SUPPL2008-01-09
5921SUPPL2007-11-08
44607SUPPL2007-11-07
5922SUPPL2007-07-05
5920SUPPL2007-02-12
37404SUPPL2007-02-02
28316SUPPL2006-07-13
42253ORIG2005-01-11
28315ORIG2004-11-16
15924ORIG2004-11-16