aliskiren / Amlodipine / Hydrochlorothiazide Oral Tablet

Brand(s)
Amturnide
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2010-12-21
License(s)
NDA
RxNORM
ORAL TABLET\ALISKIREN:AMLODIPINE:HYDROCHLOROTHIAZIDE
FDAOB
ORAL\TABLET\ALISKIREN HEMIFUMARATE: AMLODIPINE BESYLATE: HYDROCHLOROTHIAZIDE
SPL Active
ORAL\TABLET, FILM COATED\ALISKIREN HEMIFUMARATE: AMLODIPINE BESYLATE: HYDROCHLOROTHIAZIDE
SPL Moiety
ORAL\TABLET, FILM COATED\ALISKIREN: AMLODIPINE: HYDROCHLOROTHIAZIDE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780610AmturnideNDANovartis Pharmaceuticals Corporation2010-12-212015-09-30ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA2000450a5c7e83-3b17-4412-89fb-ff2235cbe77c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780613AmturnideNDANovartis Pharmaceuticals Corporation2010-12-212015-10-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA2000450a5c7e83-3b17-4412-89fb-ff2235cbe77c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780614AmturnideNDANovartis Pharmaceuticals Corporation2010-12-212016-01-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA2000450a5c7e83-3b17-4412-89fb-ff2235cbe77c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780611AmturnideNDANovartis Pharmaceuticals Corporation2010-12-212016-01-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA2000450a5c7e83-3b17-4412-89fb-ff2235cbe77c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780612AmturnideNDANovartis Pharmaceuticals Corporation2010-12-212016-03-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDEORALTABLET, FILM COATEDNDA2000450a5c7e83-3b17-4412-89fb-ff2235cbe77c

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA200045AMTURNIDETrueNOVARTIS PHARMACEUTICALS CORP2010-12-21p8183295, SUBSTANCE
p8618174, SUBSTANCE
p5559111, TREATMENT OF HYPERTENSION, SUBSTANCE
NDA200045_001, NDA200045_002, NDA200045_003, NDA200045_004, NDA200045_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200045_001discontinuedALISKIREN HEMIFUMARATE (EQ 150MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE), HYDROCHLOROTHIAZIDE (12.5MG)ORALTABLETFalse2010-12-21AMTURNIDE
2NDA200045_002discontinuedALISKIREN HEMIFUMARATE (EQ 300MG BASE), HYDROCHLOROTHIAZIDE (12.5MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalse2010-12-21AMTURNIDE
3NDA200045_003discontinuedAMLODIPINE BESYLATE (EQ 5MG BASE), ALISKIREN HEMIFUMARATE (EQ 300MG BASE), HYDROCHLOROTHIAZIDE (25MG)ORALTABLETFalse2010-12-21AMTURNIDE
4NDA200045_004discontinuedAMLODIPINE BESYLATE (EQ 10MG BASE), HYDROCHLOROTHIAZIDE (12.5MG), ALISKIREN HEMIFUMARATE (EQ 300MG BASE)ORALTABLETFalse2010-12-21AMTURNIDE
5NDA200045_005discontinuedALISKIREN HEMIFUMARATE (EQ 300MG BASE), HYDROCHLOROTHIAZIDE (25MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalse2010-12-21AMTURNIDE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5559111 (view patent)2018-07-21NDA200045, NDA021985, NDA022107, NDA022217, NDA022545aliskiren / Amlodipine Oral Tablet
aliskiren Oral Tablet
aliskiren / Hydrochlorothiazide Oral Tablet
2p8183295 (view patent)2023-05-16NDA200045
3p8618174 (view patent)2021-11-15NDA200045

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10a5c7e83-3b17-4412-89fb-ff2235cbe77c (view SPL)These highlights do not include all the information needed to use AMTURNIDE safely and effectively. See full prescribing information for AMTURNIDE. AmturnideTM (aliskiren, amlodipine and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2010prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-03-2717000780610, 000780611, 000780612, 000780613, 000780614

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII