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Approved Drug Products containing 203389 listed in the FDA Orange Book. Original Data : FDA Website

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01 HORIZON (2)

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01 CAPSULE, DELAYED RELEASE;ORAL (2)

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01 RX (2)

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01 PROCYSBI (2)

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01 Yes (2)

URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 25MG BASE
2013-04-30
203389
PROCYSBI
RX
Yes
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URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 75MG BASE
2013-04-30
203389
PROCYSBI
RX
Yes
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PHARMACOMPASS
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your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 203389

Looking for FDA Orange Book APPLICATION 203389 2

19

Horizon Therapeutics, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CYSTEAMINE BITARTRATE, with a corresponding application number 203389.

Regulatory Information RX

With a dosage strength EQ 25MG BASE

Dosage Form Route CAPSULE, DELAYED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-04-30

18

Horizon Therapeutics, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is CYSTEAMINE BITARTRATE, with a corresponding application number 203389.

Regulatory Information RX

With a dosage strength EQ 75MG BASE

Dosage Form Route CAPSULE, DELAYED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-04-30

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