FDA.reportPublic FDA data

Application 204857

Type
ANDA
Sponsor
AMNEAL PHARMS NY

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
42291-860LacosamideLacosamideAvKAREANDACurrent
42291-861LacosamideLacosamideAvKAREANDACurrent
42291-862LacosamideLacosamideAvKAREANDACurrent
42291-863LacosamideLacosamideAvKAREANDACurrent
65162-923LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-923LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-924LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-924LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-925LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-925LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-926LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent
65162-926LacosamideLacosamideAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52759ORIG2018-02-28