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)
# | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 000780604 | Tekamlo | NDA | Novartis Pharmaceuticals Corporation | 2010-01-01 | 2016-03-31 | ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE | ORAL | TABLET, FILM COATED | NDA022545 | 78a3bdb0-c945-45cf-b75d-066dbf1d152c |
invalid application product(s)
# | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 000780603 | Tekamlo | NDA | Novartis Pharmaceuticals Corporation | 2010-01-01 | 2016-03-31 | ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE | ORAL | TABLET, FILM COATED | NDA022545 | 78a3bdb0-c945-45cf-b75d-066dbf1d152c |
invalid application product(s)
# | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 000780606 | Tekamlo | NDA | Novartis Pharmaceuticals Corporation | 2010-01-01 | 2015-10-31 | ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE | ORAL | TABLET, FILM COATED | NDA022545 | 78a3bdb0-c945-45cf-b75d-066dbf1d152c |
invalid application product(s)
# | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 000780605 | Tekamlo | NDA | Novartis Pharmaceuticals Corporation | 2010-01-01 | 2015-09-30 | ALISKIREN HEMIFUMARATE, AMLODIPINE BESYLATE | ORAL | TABLET, FILM COATED | NDA022545 | 78a3bdb0-c945-45cf-b75d-066dbf1d152c |
application(s)
# | id | title | deprecated | applicant | approved | patent | approved drug |
---|---|---|---|---|---|---|---|
1 | NDA022545 | TEKAMLO | True | NOVARTIS PHARMACEUTICALS CORP | 2010-08-26 | p8613949, SUBSTANCE p5559111, TREATMENT OF HYPERTENSION, SUBSTANCE | NDA022545_001, NDA022545_002, NDA022545_003, NDA022545_004 |
application drug(s)
# | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
---|---|---|---|---|---|---|---|---|
1 | NDA022545_001 | discontinued | AMLODIPINE BESYLATE (EQ 5MG BASE), ALISKIREN HEMIFUMARATE (EQ 150MG BASE) | ORAL | TABLET | False | 2010-08-26 | TEKAMLO |
2 | NDA022545_002 | discontinued | ALISKIREN HEMIFUMARATE (EQ 150MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE) | ORAL | TABLET | False | 2010-08-26 | TEKAMLO |
3 | NDA022545_003 | discontinued | AMLODIPINE BESYLATE (EQ 5MG BASE), ALISKIREN HEMIFUMARATE (EQ 300MG BASE) | ORAL | TABLET | False | 2010-08-26 | TEKAMLO |
4 | NDA022545_004 | discontinued | ALISKIREN HEMIFUMARATE (EQ 300MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE) | ORAL | TABLET | False | 2010-08-26 | TEKAMLO |
patent(s)
# | id | expiration date | application(s) | in other drug docs |
---|---|---|---|---|
1 | p5559111 (view patent) | 2018-07-21 | NDA022545, NDA021985, NDA022107, NDA022217, NDA200045 | aliskiren / Amlodipine / Hydrochlorothiazide Oral Tablet aliskiren Oral Tablet aliskiren / Hydrochlorothiazide Oral Tablet |
2 | p8613949 (view patent) | 2029-12-21 | NDA022545 |
spl(s)
# | id | title | category | type | labeler | last update | version | product(s) |
---|---|---|---|---|---|---|---|---|
1 | 78a3bdb0-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: 2010 | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2015-03-27 | 16 | 000780603, 000780604, 000780605, 000780606 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII