FDA.reportPublic FDA data

Application 208181

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDETABLET;ORAL2MGNoNo
002TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDETABLET;ORAL4MGNoNo
003TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDETABLET;ORAL12MGNoNo
004TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDETABLET;ORAL16MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1104Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1104Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1104Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals LLCANDACurrent
69238-1104Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1104Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1104Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1105Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1105Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1105Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1105Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals LLCANDACurrent
69238-1105Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1105Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1106Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1106Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1106Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1106Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals LLCANDACurrent
69238-1106Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1106Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1107Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1107Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1107Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1107Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals LLCANDACurrent
69238-1107Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1107Tiagabine HydrochlorideTiagabineAmneal Pharmaceuticals NY LLCANDACurrent