FDA.reportPublic FDA data

Application 021093

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATACAND HCTCANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL16MG;12.5MGYesNo
002ATACAND HCTCANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL32MG;12.5MGYesNo
003ATACAND HCTCANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL32MG;25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0162ATACAND HCTCandesartan cilexetil and HydrochlorothiazideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0322ATACAND HCTCandesartan cilexetil and HydrochlorothiazideAstraZeneca Pharmaceuticals LPNDACurrent
0186-0324ATACAND HCTCandesartan cilexetil HydrochlorothiazideAstraZeneca Pharmaceuticals LPNDACurrent
62559-650ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-650ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-650ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-651ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-651ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-651ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-652ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-652ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-652ATACAND HCTCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDACurrent
62559-660Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-660Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-660Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-661Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-661Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-661Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-662Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-662Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-662Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
63629-3377ATACAND HCTCandesartan cilexetil and HydrochlorothiazideBryant Ranch PrepackNDACurrent
63629-3377ATACAND HCTCandesartan cilexetil and HydrochlorothiazideBryant Ranch PrepackNDACurrent
70518-2720Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2720Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2720Candesartan Cilexetil and HydrochlorothiazideCandesartan Cilexetil and HydrochlorothiazideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64429SUPPL2020-08-27
64381SUPPL2020-08-24
14381SUPPL2016-03-04
4322SUPPL2016-02-11
14380SUPPL2015-02-10
4320SUPPL2015-02-10
4321SUPPL2013-04-30
36107SUPPL2013-04-29
4319SUPPL2012-04-02
36106SUPPL2012-03-29
44096ORIG2011-12-22
4318SUPPL2011-06-17
36105SUPPL2011-06-16
4317SUPPL2011-03-16
14379SUPPL2011-03-11
26758SUPPL2008-05-20
26757SUPPL2006-08-18
14378SUPPL2006-08-18
4316SUPPL2004-12-30
21446ORIG2004-05-27
26756ORIG2000-09-05
14377ORIG2000-09-05