FDA.reportPublic FDA data

Application 204787

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACOSAMIDELACOSAMIDETABLET;ORAL50MGNoNo
002LACOSAMIDELACOSAMIDETABLET;ORAL100MGNoNo
003LACOSAMIDELACOSAMIDETABLET;ORAL150MGNoNo
004LACOSAMIDELACOSAMIDETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-812LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-812LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-812LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-813LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-813LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-813LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-814LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-814LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-814LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-815LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-815LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent
31722-815LACOSAMIDELACOSAMIDECamber Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71753ORIG2022-08-09