FDA.reportPublic FDA data

Application 205231

Type
ANDA
Sponsor
TWI PHARMS

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
0904-7217Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7218Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7219Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7220Diltiazem HydrochlorideDiltiazem hydrochlorideMajor PharmaceuticalsANDACurrent
24979-026Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-027Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-028Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-029Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-030Diltiazem HydrochlorideDiltiazem hydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
50090-5416Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5416Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5452Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5452Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5466Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5466Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
50090-5466Diltiazem HydrochlorideDiltiazem hydrochlorideA-S Medication SolutionsANDACurrent
51407-473Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-473Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-474Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-474Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-475Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-475Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-476Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-476Diltiazem HydrochlorideDiltiazem hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2506Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2789Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2789Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3337Diltiazem HydrochlorideDiltiazem hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-564Diltiazem HydrochlorideDiltiazem hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-565Diltiazem HydrochlorideDiltiazem hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-2129Diltiazem HydrochlorideDiltiazem hydrochlorideBryant Ranch PrepackANDACurrent