FDA.reportPublic FDA data

Application 201680

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FELBAMATEFELBAMATETABLET;ORAL400MGNoNo
002FELBAMATEFELBAMATETABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-601FelbamateFelbamateMarlex Pharmaceuticals IncANDACurrent
10135-602FelbamateFelbamateMarlex Pharmaceuticals IncANDACurrent
53746-734FelbamateFelbamateAmneal Pharmaceuticals of New York LLCANDACurrent
53746-735FelbamateFelbamateAmneal Pharmaceuticals of New York LLCANDACurrent
65162-734FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-734FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-734FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-734FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-735FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-735FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-735FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
65162-735FelbamateFelbamateAmneal Pharmaceuticals LLCANDACurrent
68151-4474FelbamateFelbamateCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9921ORIG2011-09-15