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Approved Drug Products containing 22291 listed in the FDA Orange Book. Original Data : FDA Website

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01 NOVARTIS (5)

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01 TABLET;ORAL (5)

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01 DISCN (1)

02 RX (4)

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01 PROMACTA (5)

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01 Yes (5)

URL Supplier Web Content
TABLET; ORAL
EQ 75MG ACID
2009-09-08
22291
PROMACTA
RX
Yes
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TABLET; ORAL
EQ 25MG ACID
2008-11-20
22291
PROMACTA
RX
Yes
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TABLET; ORAL
EQ 12.5MG ACID
2011-10-20
22291
PROMACTA
RX
Yes
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TABLET; ORAL
EQ 50MG ACID
2008-11-20
22291
PROMACTA
RX
Yes
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TABLET; ORAL
EQ 100MG ACID **Fe...
2012-11-16
22291
PROMACTA
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 22291

Looking for FDA Orange Book APPLICATION 22291 5

19

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ELTROMBOPAG OLAMINE, with a corresponding application number 22291.

Regulatory Information RX

With a dosage strength EQ 75MG ACID

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2009-09-08

18

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ELTROMBOPAG OLAMINE, with a corresponding application number 22291.

Regulatory Information RX

With a dosage strength EQ 25MG ACID

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2008-11-20

17

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ELTROMBOPAG OLAMINE, with a corresponding application number 22291.

Regulatory Information RX

With a dosage strength EQ 12.5MG ACID

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2011-10-20

16

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ELTROMBOPAG OLAMINE, with a corresponding application number 22291.

Regulatory Information RX

With a dosage strength EQ 50MG ACID

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2008-11-20

15

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ELTROMBOPAG OLAMINE, with a corresponding application number 22291.

Regulatory Information DISCN

With a dosage strength EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2012-11-16

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