aliskiren / Amlodipine Oral Tablet

Brand(s)
Tekamlo
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2010-01-01
License(s)
NDA
RxNORM
ORAL TABLET\ALISKIREN:AMLODIPINE
FDAOB
ORAL\TABLET\ALISKIREN HEMIFUMARATE: AMLODIPINE BESYLATE
SPL Active
ORAL\TABLET, FILM COATED\ALISKIREN HEMIFUMARATE: AMLODIPINE BESYLATE
SPL Moiety
ORAL\TABLET, FILM COATED\ALISKIREN: AMLODIPINE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780604TekamloNDANovartis Pharmaceuticals Corporation2010-01-012016-03-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATEORALTABLET, FILM COATEDNDA02254578a3bdb0-c945-45cf-b75d-066dbf1d152c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780603TekamloNDANovartis Pharmaceuticals Corporation2010-01-012016-03-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATEORALTABLET, FILM COATEDNDA02254578a3bdb0-c945-45cf-b75d-066dbf1d152c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780606TekamloNDANovartis Pharmaceuticals Corporation2010-01-012015-10-31ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATEORALTABLET, FILM COATEDNDA02254578a3bdb0-c945-45cf-b75d-066dbf1d152c

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000780605TekamloNDANovartis Pharmaceuticals Corporation2010-01-012015-09-30ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATEORALTABLET, FILM COATEDNDA02254578a3bdb0-c945-45cf-b75d-066dbf1d152c

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA022545TEKAMLOTrueNOVARTIS PHARMACEUTICALS CORP2010-08-26p8613949, SUBSTANCE
p5559111, TREATMENT OF HYPERTENSION, SUBSTANCE
NDA022545_001, NDA022545_002, NDA022545_003, NDA022545_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022545_001discontinuedAMLODIPINE BESYLATE (EQ 5MG BASE), ALISKIREN HEMIFUMARATE (EQ 150MG BASE)ORALTABLETFalse2010-08-26TEKAMLO
2NDA022545_002discontinuedALISKIREN HEMIFUMARATE (EQ 150MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalse2010-08-26TEKAMLO
3NDA022545_003discontinuedAMLODIPINE BESYLATE (EQ 5MG BASE), ALISKIREN HEMIFUMARATE (EQ 300MG BASE)ORALTABLETFalse2010-08-26TEKAMLO
4NDA022545_004discontinuedALISKIREN HEMIFUMARATE (EQ 300MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalse2010-08-26TEKAMLO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5559111 (view patent)2018-07-21NDA022545, NDA021985, NDA022107, NDA022217, NDA200045aliskiren / Amlodipine / Hydrochlorothiazide Oral Tablet
aliskiren Oral Tablet
aliskiren / Hydrochlorothiazide Oral Tablet
2p8613949 (view patent)2029-12-21NDA022545

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
178a3bdb0-c945-45cf-b75d-066dbf1d152c (view SPL)These highlights do not include all the information needed to use TEKAMLO safely and effectively. See full prescribing information for TEKAMLO. TEKAMLO (aliskiren and amlodipine) tablets, for oral use Initial U.S. Approval: 2010prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-03-2716000780603, 000780604, 000780605, 000780606

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