FDA.reportPublic FDA data

Application 076684

Type
ANDA
Sponsor
AMPHASTAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS30MG/0.3ML (100MG/ML)NoNo
002ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS40MG/0.4ML (100MG/ML)NoNo
003ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS60MG/0.6ML (100MG/ML)NoNo
004ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS80MG/0.8ML (100MG/ML)NoNo
005ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS100MG/ML (100MG/ML)NoNo
006ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS120MG/0.8ML (150MG/ML)NoNo
007ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUMINJECTABLE;SUBCUTANEOUS150MG/ML (150MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0548-5601Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5601Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5601Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5601Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5601Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5601Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5602Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5602Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5602Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5602Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5602Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5602Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5603Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5603Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5603Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5603Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5603Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5603Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5604Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5604Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5604Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5604Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5604Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5604Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5605Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5605Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5605Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5605Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5605Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5605Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5606Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5606Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5606Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5606Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5606Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5606Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5607Enoxaparin SodiumEnoxaparin sodiumAmphastar PharmaceuticalsANDACurrent
0548-5607Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5607Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5607Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5607Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5607Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5631Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5632Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5633Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5634Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5635Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5636Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5637Enoxaparin SodiumEnoxaparin sodiumAmphastar Pharmaceuticals, Inc.ANDACurrent
68001-457Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-457Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-457Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-457Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-458Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-458Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-458Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-458Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-459Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-459Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-459Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-459Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-460Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-460Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-460Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-460Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-461Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-461Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-461Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-461Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-462Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-462Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-462Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-462Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-463Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-463Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-463Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent
68001-463Enoxaparin SodiumEnoxaparin sodiumBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22578ORIG2012-02-14