FDA.reportPublic FDA data

Application 211292

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FROVATRIPTAN SUCCINATEFROVATRIPTAN SUCCINATETABLET;ORALEQ 2.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1539FrovatriptanFrovatriptan succinateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1539FrovatriptanFrovatriptan succinateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1539FrovatriptanFrovatriptan succinateAmneal Pharmaceuticals LLCANDACurrent
69238-1539FrovatriptanFrovatriptan succinateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1539FrovatriptanFrovatriptan succinateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1539FrovatriptanFrovatriptan succinateAmneal Pharmaceuticals NY LLCANDACurrent