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