FDA.reportPublic FDA data

Application 074752

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo
002CARTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
003CARTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoNo
004CARTIA XTDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3051CartiaDiltiazem HydrochlorideA-S Medication SolutionsANDACurrent
50090-3051CartiaDiltiazem HydrochlorideA-S Medication SolutionsANDACurrent
50090-3124CartiaDiltiazem HydrochlorideA-S Medication SolutionsANDACurrent
50090-3124CartiaDiltiazem HydrochlorideA-S Medication SolutionsANDACurrent
62037-597CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-597CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-597CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-597CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-598CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-598CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-598CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-598CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-599CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-599CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-599CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-599CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-600CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-600CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-600CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
62037-600CartiaDiltiazem HydrochlorideActavis Pharma, Inc.ANDACurrent
63629-7896CartiaDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
63629-7896CartiaDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
63629-7896CartiaDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
70518-1537CartiaDiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1537CartiaDiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1537CartiaDiltiazem HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0879CartiaDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0879CartiaDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
71335-0879CartiaDiltiazem HydrochlorideBryant Ranch PrepackANDACurrent
72189-344CARTIA XTdiltiazem hydrochlorideDirectRxANDACurrent
72189-344CARTIA XTdiltiazem hydrochlorideDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42875SUPPL2005-07-22
42874SUPPL2005-07-22
42873SUPPL2005-07-22
42872SUPPL2005-07-22
42871SUPPL2005-07-22
42870SUPPL2005-07-22
42869SUPPL2005-07-22
42868SUPPL2005-07-22
22366SUPPL2005-07-22
22365SUPPL2005-07-22
22364SUPPL2005-07-22
22363SUPPL2005-07-22
22362SUPPL2005-07-22
22361SUPPL2005-07-22
22360SUPPL2005-07-22
22359SUPPL2005-07-22
22358ORIG2005-07-22
30694ORIG1998-07-09
18365ORIG1998-07-09