FDA.reportPublic FDA data

Application 090492

Type
ANDA
Sponsor
SUN PHARM

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
004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo
005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL360MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-675Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-676Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-677Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-678Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-679Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
53217-006Diltiazem HydrochlorideDiltiazem HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
63629-7232Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
63629-7232Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
68071-1914Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1925Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1928Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6893Diltiazem HydrochlorideDiltiazem HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6893Diltiazem HydrochlorideDiltiazem HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6893Diltiazem HydrochlorideDiltiazem HydrochloridePreferred PHarmaceuticals Inc.ANDACurrent