FDA.reportPublic FDA data

Application 076856

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DANTROLENE SODIUMDANTROLENE SODIUMCAPSULE;ORAL25MGNoNo
002DANTROLENE SODIUMDANTROLENE SODIUMCAPSULE;ORAL50MGNoNo
003DANTROLENE SODIUMDANTROLENE SODIUMCAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-4411Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4411Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4411Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4411Dantrolene SodiumDantrolene SodiumImpax GenericsANDACurrent
0115-4422Dantrolene SodiumDantrolene SodiumImpax GenericsANDACurrent
0115-4422Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4422Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4422Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4433Dantrolene SodiumDantrolene SodiumImpax GenericsANDACurrent
0115-4433Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4433Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-4433Dantrolene SodiumDantrolene SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0904-7211Dantrolene SodiumDantrolene SodiumMajor PharmaceuticalsANDACurrent
50268-217Dantrolene SodiumDantrolene SodiumAvPAKANDACurrent
50268-217Dantrolene SodiumDantrolene SodiumAvPAKANDACurrent
50268-217Dantrolene SodiumDantrolene SodiumAvPAKANDACurrent
55154-7140Dantrolene SodiumDantrolene SodiumCardinal HealthANDACurrent
55154-7140Dantrolene SodiumDantrolene SodiumCardinal HealthANDACurrent
55154-7140Dantrolene SodiumDantrolene SodiumCardinal Health 107, LLCANDACurrent
55154-7140Dantrolene SodiumDantrolene SodiumCardinal HealthANDACurrent
68084-300Dantrolene SodiumDantrolene SodiumAmerican Health PackagingANDACurrent
68084-300Dantrolene SodiumDantrolene SodiumAmerican Health PackagingANDACurrent
68084-300Dantrolene SodiumDantrolene SodiumAmerican Health PackagingANDACurrent
68084-300Dantrolene SodiumDantrolene SodiumAmerican Health PackagingANDACurrent
68084-300Dantrolene SodiumDantrolene SodiumAmerican Health PackagingANDACurrent
68151-1520Dantrolene SodiumDantrolene SodiumCarilion Materials ManagementANDACurrent