FDA.reportPublic FDA data

Application 090421

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
47335-669Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-669Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-670Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-670Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-671Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-671Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-672Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-672Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-673Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-673Diltiazem HydrochlorideDiltiazem HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
70518-2241Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent