FDA.reportPublic FDA data

Application 208804

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 2MG BASENoNo
002ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1344AlbuterolAlbuterolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1344AlbuterolAlbuterolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1344AlbuterolAlbuterolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1344AlbuterolAlbuterolAmneal Pharmaceuticals LLCANDACurrent
69238-1345AlbuterolAlbuterolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1345AlbuterolAlbuterolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1345AlbuterolAlbuterolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1345AlbuterolAlbuterolAmneal Pharmaceuticals LLCANDACurrent