FDA.reportPublic FDA data

Application 074007

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACEBUTOLOL HYDROCHLORIDEACEBUTOLOL HYDROCHLORIDECAPSULE;ORALEQ 200MG BASENoNo
002ACEBUTOLOL HYDROCHLORIDEACEBUTOLOL HYDROCHLORIDECAPSULE;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-666Acebutolol HydrochlorideAcebutolol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-667Acebutolol HydrochlorideAcebutolol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
62559-255Acebutolol HydrochlorideAcebutolol HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-255Acebutolol HydrochlorideAcebutolol HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-256Acebutolol HydrochlorideAcebutolol HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-256Acebutolol HydrochlorideAcebutolol HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent