FDA.reportPublic FDA data

Application 020164

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS30MG/0.3ML (100MG/ML)YesNo
002LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS40MG/0.4ML (100MG/ML)YesNo
003LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS60MG/0.6ML (100MG/ML)YesNo
004LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS80MG/0.8ML (100MG/ML)YesNo
005LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS100MG/ML (100MG/ML)YesYes
006LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
007LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS120MG/0.8ML (150MG/ML)YesNo
008LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS150MG/ML (150MG/ML)YesNo
009LOVENOXENOXAPARIN SODIUMINJECTABLE;INTRAVENOUS, SUBCUTANEOUS300MG/3ML (100MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0075-0620Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0620Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0620Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-0620Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0620Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0620Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0621Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0621Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0621Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0621Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-0621Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0621Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0622Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0622Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0622Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0622Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-0622Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0622Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0623Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0623Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0623Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0623Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-0623Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0623Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0624Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0624Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0624Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0624Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-0624Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0624Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0626Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0626Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0626Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0626Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-0626Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-0626Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2912Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2912Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2912Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2912Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-2912Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2912Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2915Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2915Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2915Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2915Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-2915Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-2915Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8013Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8013Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-8013Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8013Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8013Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8014Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8014Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-8014Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8014Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8014Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8016Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8016Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-8016Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8016Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8016Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8018Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8018Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8018Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8018Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8018Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-8020Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8020Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-8020Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8020Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8020Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8022Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8022Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8022Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8022Lovenoxenoxaparin sodiumsanofi-aventis U.S. LLCNDACurrent
0075-8022Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8025Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent
0075-8025Lovenoxenoxaparin sodiumSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74941SUPPL 2023-07-31
74940SUPPL 2023-07-31
72775SUPPL2022-12-05
72770SUPPL2022-12-02
69729SUPPL2021-12-21
69699SUPPL2021-12-20
56839SUPPL2018-12-20
56710SUPPL2018-12-12
50280SUPPL2017-11-03
50238SUPPL2017-10-31
44049ORIG2013-11-07
34335SUPPL2013-10-31
21249SUPPL2013-10-25
34334SUPPL2013-06-11
2128SUPPL2013-06-07
2127SUPPL2011-04-22
12290SUPPL2011-04-21
34333SUPPL2011-04-19
2126SUPPL2011-04-15
21248SUPPL2009-12-31
12289SUPPL2009-12-30
21247SUPPL2009-07-31
34332SUPPL2009-07-30
20515SUPPL2009-03-24
41182SUPPL2008-08-11
20506SUPPL2008-08-11
20505SUPPL2008-08-11
20504SUPPL2008-08-11
20503SUPPL2008-08-11
41188SUPPL2008-08-08
41187SUPPL2008-08-08
41186SUPPL2008-08-08
41184SUPPL2008-08-08
20509SUPPL2008-08-08
20508SUPPL2008-08-08
20507SUPPL2008-08-08
41197SUPPL2008-08-04
41196SUPPL2008-08-04
41195SUPPL2008-08-04
41194SUPPL2008-08-04
41193SUPPL2008-08-04
41192SUPPL2008-08-04
41191SUPPL2008-08-04
41190SUPPL2008-08-04
41189SUPPL2008-08-04
20511SUPPL2008-08-04
41198SUPPL2008-08-01
20514SUPPL2008-08-01
20512SUPPL2008-08-01
20510SUPPL2008-08-01
12288SUPPL2008-07-22
21246SUPPL2008-07-18
41200SUPPL2007-07-09
41199SUPPL2007-07-09
21245SUPPL2007-05-29
12287SUPPL2007-05-29
34331SUPPL2007-01-16
2125SUPPL2007-01-16
20513SUPPL2006-10-26
2124SUPPL2005-03-10
21241SUPPL2004-10-26
21242SUPPL2004-07-28
12286SUPPL2004-07-28
20502ORIG2004-07-15
2114SUPPL2004-06-08
2123SUPPL2004-05-26
21244SUPPL2004-04-29
21243SUPPL2004-04-20
34328ORIG2004-04-05
21236ORIG2004-02-25
2120SUPPL2003-12-23
2121SUPPL2003-07-08
2122SUPPL2003-07-06
41183SUPPL2003-04-29
21239SUPPL2003-01-23
21240SUPPL2002-01-09
21238SUPPL2002-01-09
2119SUPPL2002-01-09
34330SUPPL2000-11-17
21237SUPPL2000-11-17
12285SUPPL2000-11-17
2118SUPPL2000-11-17
2117SUPPL2000-09-27
2116SUPPL2000-08-04
41185SUPPL2000-07-03
34329SUPPL1998-12-31
2115SUPPL1998-12-31