Enoxaparin Injectable Solution

Brand(s)
Lovenox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2013-10-29)
Oldest Current Product
1993-03-29
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\ENOXAPARIN
FDAOB
INTRAVENOUS, SUBCUTANEOUS\INJECTION\ENOXAPARIN SODIUM\rdfq
SUBCUTANEOUS\INJECTION\ENOXAPARIN SODIUM
SPL Active
INTRAVENOUS\INJECTION\ENOXAPARIN SODIUM
SUBCUTANEOUS\INJECTION\ENOXAPARIN SODIUM
SPL Moiety
INTRAVENOUS\INJECTION\ENOXAPARIN
SUBCUTANEOUS\INJECTION\ENOXAPARIN

product(s) by strength(s)

enoxaparin sodium 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000758030LovenoxNDASanofi-Aventis U.S. Llc1993-03-29ENOXAPARIN SODIUMINTRAVENOUSINJECTIONNDA020164de6fb917-a94a-41ea-9d7d-937d4080ffcd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813122ANDASandoz Inc2012-04-23ENOXAPARIN SODIUMINTRAVENOUSINJECTIONANDA078660bbebb81f-5137-4097-b91f-7ee87bd12bcf
2009551016NDA AUTHORIZED GENERICWinthrop U.S.2011-10-03ENOXAPARIN SODIUMSUBCUTANEOUSINJECTIONNDA02016420635579-c92d-4f6c-a332-1096d51002f2
3633230565NDA, NDA AUTHORIZED GENERICApp Pharmaceuticals, Llc2015-02-20, 2015-03-15ENOXAPARIN SODIUMSUBCUTANEOUSINJECTIONNDA0201642cc08d08-555a-4135-b6da-9f8cf7b11ad7, ad58d8b7-fc98-45ee-ab49-6b59193f3c60

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA076684ENOXAPARIN SODIUM (PRESERVATIVE FREE)AMPHASTAR PHARMACEUTICAL INC2011-09-19ANDA076684_001, ANDA076684_002, ANDA076684_003, ANDA076684_004, ANDA076684_005, ANDA076684_006, ANDA076684_007Enoxaparin Prefilled Syringe
2ANDA076726ENOXAPARIN SODIUM (PRESERVATIVE FREE)TEVA PHARMACEUTICALS USA INC2014-06-23ANDA076726_001, ANDA076726_002, ANDA076726_003, ANDA076726_004, ANDA076726_005, ANDA076726_006, ANDA076726_007Enoxaparin Prefilled Syringe
3ANDA077857ENOXAPARIN SODIUM (PRESERVATIVE FREE)SANDOZ INC2010-07-23ANDA077857_001, ANDA077857_002, ANDA077857_003, ANDA077857_004, ANDA077857_005, ANDA077857_006, ANDA077857_007Enoxaparin Prefilled Syringe
4ANDA078660ENOXAPARIN SODIUMSANDOZ INC2011-11-28ANDA078660_001Enoxaparin Prefilled Syringe
5NDA020164LOVENOXSANOFI AVENTIS US LLC1993-03-29NDA020164_001, NDA020164_002, NDA020164_003, NDA020164_004, NDA020164_005, NDA020164_006, NDA020164_007, NDA020164_008, NDA020164_009Enoxaparin Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076684_001RXENOXAPARIN SODIUM (30MG/0.3ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
2ANDA076684_002RXENOXAPARIN SODIUM (40MG/0.4ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
3ANDA076684_003RXENOXAPARIN SODIUM (60MG/0.6ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
4ANDA076684_004RXENOXAPARIN SODIUM (80MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
5ANDA076684_005RXENOXAPARIN SODIUM (100MG/ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
6ANDA076684_006RXENOXAPARIN SODIUM (120MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
7ANDA076684_007RXENOXAPARIN SODIUM (150MG/ML)SUBCUTANEOUSINJECTIONFalseAP2011-09-19ENOXAPARIN SODIUM (PRESERVATIVE FREE)
8ANDA076726_001RXENOXAPARIN SODIUM (30MG/0.3ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
9ANDA076726_002RXENOXAPARIN SODIUM (40MG/0.4ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
10ANDA076726_003RXENOXAPARIN SODIUM (60MG/0.6ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
11ANDA076726_004RXENOXAPARIN SODIUM (80MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
12ANDA076726_005RXENOXAPARIN SODIUM (100MG/ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
13ANDA076726_006RXENOXAPARIN SODIUM (120MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
14ANDA076726_007RXENOXAPARIN SODIUM (150MG/ML)SUBCUTANEOUSINJECTIONFalseAP2014-06-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
15ANDA077857_001RXENOXAPARIN SODIUM (100MG/ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
16ANDA077857_002RXENOXAPARIN SODIUM (30MG/0.3ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
17ANDA077857_003RXENOXAPARIN SODIUM (40MG/0.4ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
18ANDA077857_004RXENOXAPARIN SODIUM (60MG/0.6ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
19ANDA077857_005RXENOXAPARIN SODIUM (80MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
20ANDA077857_006RXENOXAPARIN SODIUM (120MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
21ANDA077857_007RXENOXAPARIN SODIUM (150MG/ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-23ENOXAPARIN SODIUM (PRESERVATIVE FREE)
22ANDA078660_001RXENOXAPARIN SODIUM (300MG/3ML)INJECTIONFalseAB2011-11-28ENOXAPARIN SODIUM
23NDA020164_001RXENOXAPARIN SODIUM (30MG/0.3ML)SUBCUTANEOUSINJECTIONFalseAP1993-03-29LOVENOX
24NDA020164_002RXENOXAPARIN SODIUM (40MG/0.4ML)SUBCUTANEOUSINJECTIONFalseAP1998-01-30LOVENOX
25NDA020164_003RXENOXAPARIN SODIUM (60MG/0.6ML)SUBCUTANEOUSINJECTIONFalseAP1998-03-27LOVENOX
26NDA020164_004RXENOXAPARIN SODIUM (80MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP1998-03-27LOVENOX
27NDA020164_005RXENOXAPARIN SODIUM (100MG/ML)SUBCUTANEOUSINJECTIONTrueAP1998-03-27LOVENOX
28NDA020164_006discontinuedENOXAPARIN SODIUM (90MG/0.6ML)SUBCUTANEOUSINJECTIONFalse2000-06-02LOVENOX
29NDA020164_007RXENOXAPARIN SODIUM (120MG/0.8ML)SUBCUTANEOUSINJECTIONFalseAP2000-06-02LOVENOX
30NDA020164_008RXENOXAPARIN SODIUM (150MG/ML)SUBCUTANEOUSINJECTIONFalseAP2000-06-02LOVENOX
31NDA020164_009RXENOXAPARIN SODIUM (300MG/3ML)INJECTIONFalseAB2003-01-23LOVENOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
120635579-c92d-4f6c-a332-1096d51002f2 (view SPL)These highlights do not include all the information needed to use enoxaparin sodium injection safely and effectively. See full prescribing information for enoxaparin sodium injection.Enoxaparin sodium injection for subcutaneous and intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionWinthrop U.S.ANALYSIS, LABEL, MANUFACTURE, PACK2013-11-188009551016, 009551003, 009551004, 009551006, 009551008, 009551010, 009551012, 009551015Enoxaparin Prefilled Syringe
22cc08d08-555a-4135-b6da-9f8cf7b11ad7 (view SPL)These highlights do not include all the information needed to use enoxaparin sodium injection safely and effectively. See full prescribing information for enoxaparin sodium injection.Enoxaparin sodium injection for subcutaneous and intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionApp Pharmaceuticals, LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-12-011633230565, 633230568, 633230569Enoxaparin Prefilled Syringe
35017a927-2a24-4f27-89f9-27c805bf7d59 (view SPL)These highlights do not include all the information needed to use Lovenox safely and effectively. See full prescribing information for Lovenox.Lovenox (enoxaparin sodium injection) for subcutaneous and intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2013-10-2916000750620, 000750621, 000750622, 000750623, 000750624, 000750626, 000752912, 000752915Enoxaparin Prefilled Syringe
453fd1302-9e1b-4e04-b06d-1a706547c388 (view SPL)These highlights do not include all the information needed to use Lovenox safely and effectively. See full prescribing information for Lovenox. Lovenox (enoxaparin sodium injection) for subcutaneous and intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2013-11-218000750620, 000750621, 000750622, 000750623, 000750624, 000750626, 000752912, 000752915Enoxaparin Prefilled Syringe
5ad58d8b7-fc98-45ee-ab49-6b59193f3c60 (view SPL)These highlights do not include all the information needed to use enoxaparin sodium injection safely and effectively. See full prescribing information for enoxaparin sodium injection.Enoxaparin sodium injection for subcutaneous and intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionApp Pharmaceuticals, LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-02-192633230565, 633230568, 633230569Enoxaparin Prefilled Syringe
6bbebb81f-5137-4097-b91f-7ee87bd12bcf (view SPL)These highlights do not include all the information needed to use ENOXAPARIN SODIUM safely and effectively. See full prescribing information for ENOXAPARIN SODIUM.ENOXAPARIN SODIUM injection, USP for subcutaneous and intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionSandoz Inc2015-02-1822007813122, 007813133, 007813224, 007813356, 007813428, 007813500, 007813612, 007813655Enoxaparin Prefilled Syringe
7de6fb917-a94a-41ea-9d7d-937d4080ffcd (view SPL)These highlights do not include all the information needed to use Lovenox safely and effectively. See full prescribing information for Lovenox.Lovenox (enoxaparin sodium injection) for subcutaneous and intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2013-10-293000758030, 000758013, 000758014, 000758016, 000758018, 000758020, 000758022, 000758025Enoxaparin Prefilled Syringe

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII