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Approved Drug Products containing Aliskiren listed in the FDA Orange Book. Original Data : FDA Website

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01 ANCHEN PHARMS (2)

02 NODEN PHARMA (7)

03 NOVARTIS (11)

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01 CAPSULE, PELLET;ORAL (1)

02 TABLET;ORAL (19)

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01 DISCN (16)

02 RX (4)

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01 ALISKIREN HEMIFUMARATE (2)

02 AMTURNIDE (5)

03 TEKAMLO (4)

04 TEKTURNA (3)

05 TEKTURNA HCT (4)

06 VALTURNA (2)

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01 No (13)

02 Yes (7)

URL Supplier Web Content
TABLET;ORAL
EQ 150MG BASE
2007-03-05
21985
TEKTURNA
RX
Yes
AB
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TABLET;ORAL
EQ 300MG BASE
2007-03-05
21985
TEKTURNA
RX
Yes
AB
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TABLET;ORAL
EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-01-18
22107
TEKTURNA HCT
DISCN
Yes
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TABLET;ORAL
EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-01-18
22107
TEKTURNA HCT
DISCN
Yes
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TABLET;ORAL
EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-01-18
22107
TEKTURNA HCT
DISCN
Yes
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TABLET;ORAL
EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-01-18
22107
TEKTURNA HCT
DISCN
Yes
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TABLET;ORAL
EQ 150MG BASE;160MG
2009-09-16
22217
VALTURNA
DISCN
No
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TABLET;ORAL
EQ 300MG BASE;320MG
2009-09-16
22217
VALTURNA
DISCN
No
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TABLET;ORAL
EQ 150MG BASE;EQ 5MG BASE
2010-08-26
22545
TEKAMLO
DISCN
No
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TABLET;ORAL
EQ 150MG BASE;EQ 10MG BASE
2010-08-26
22545
TEKAMLO
DISCN
No
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