FDA.reportPublic FDA data

Application 216304

Type
ANDA
Sponsor
AMTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo
003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70436-191Diltiazem HydrochlorideDiltiazem HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-191Diltiazem HydrochlorideDiltiazem HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-192Diltiazem HydrochlorideDiltiazem HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-192Diltiazem HydrochlorideDiltiazem HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-193Diltiazem HydrochlorideDiltiazem HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-193Diltiazem HydrochlorideDiltiazem HydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent