FDA.reportPublic FDA data

Application 211596

Type
ANDA
Sponsor
EDENBRIDGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDETABLET;ORAL30MGNoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDETABLET;ORAL60MGNoNo
003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDETABLET;ORAL90MGNoNo
004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDETABLET;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42799-129Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-129Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-130Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-130Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-131Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-131Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-132Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
42799-132Diltiazem HydrochlorideDiltiazem HydrochlorideEdenbridge Pharmaceuticals LLC.ANDACurrent
55154-8197Diltiazem HydrochlorideDiltiazem HydrochlorideCardinal HealthANDACurrent
60687-562Diltiazem HydrochlorideDiltiazem HydrochlorideAmerican Health PackagingANDACurrent
60687-562Diltiazem HydrochlorideDiltiazem HydrochlorideAmerican Health PackagingANDACurrent
60687-573Diltiazem HydrochlorideDiltiazem HydrochlorideAmerican Health PackagingANDACurrent
60687-573Diltiazem HydrochlorideDiltiazem HydrochlorideAmerican Health PackagingANDACurrent