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Approved Drug Products containing 202057 listed in the FDA Orange Book. Original Data : FDA Website

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01 AMARIN PHARMS (2)

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01 CAPSULE;ORAL (2)

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01 RX (2)

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01 VASCEPA (2)

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01 Yes (2)

URL Supplier Web Content
CAPSULE; ORAL
500MG
2017-02-16
202057
VASCEPA
RX
Yes
AB
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URL Supplier Web Content
CAPSULE; ORAL
1GM
2012-07-26
202057
VASCEPA
RX
Yes
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 202057

Looking for FDA Orange Book APPLICATION 202057 2

19

Amarin, based in Ireland, is a pharmaceutical company.

One of their notable products is ICOSAPENT ETHYL, with a corresponding application number 202057.

Regulatory Information RX

With a dosage strength 500MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2017-02-16

Therapeutic Equivalence (TE) Code AB

18

Amarin, based in Ireland, is a pharmaceutical company.

One of their notable products is ICOSAPENT ETHYL, with a corresponding application number 202057.

Regulatory Information RX

With a dosage strength 1GM

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-07-26

Therapeutic Equivalence (TE) Code AB

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