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Approved Drug Products of Horizon Pharma Plc listed in the FDA Orange Book. Original Data : FDA Website

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01 CYSTEAMINE BITARTRATE (4)

02 DICLOFENAC SODIUM (1)

03 ESOMEPRAZOLE MAGNESIUM; NAPROXEN (2)

04 FAMOTIDINE; IBUPROFEN (1)

05 GLYCEROL PHENYLBUTYRATE (1)

06 INTERFERON GAMMA-1B (1)

07 PEGLOTICASE (1)

08 PREDNISONE (3)

09 SODIUM PHENYLBUTYRATE (2)

10 TEPROTUMUMAB-TRBW (1)

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01 CAPSULE, DELAYED RELEASE;ORAL (2)

02 GRANULE, DELAYED RELEASE;ORAL (2)

03 INJECTABLE; INJECTION (1)

04 INJECTABLE;INJECTION (1)

05 LIQUID;ORAL (1)

06 POWDER;ORAL (1)

07 SOLUTION;TOPICAL (1)

08 TABLET, DELAYED RELEASE;ORAL (5)

09 TABLET;ORAL (2)

10 VIAL; SINGLE-USE (1)

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01 1.1GM/ML (1)

02 100UG/0.5ML (1)

03 1MG (1)

04 2% (1)

05 26.6MG;800MG (1)

06 2MG (1)

07 3GM/TEASPOONFUL (1)

08 500MG (2)

09 5MG (1)

10 8MG (1)

11 EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

12 EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

13 EQ 25MG BASE (1)

14 EQ 300MG BASE/PACKET (1)

15 EQ 75MG BASE (1)

16 EQ 75MG BASE/PACKET (1)

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01 DISCN (3)

02 RX (11)

03 Blank (3)

URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 25MG BASE
2013-04-30
203389
PROCYSBI
RX
Yes
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CAPSULE, DELAYED R...
EQ 75MG BASE
2013-04-30
203389
PROCYSBI
RX
Yes
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GRANULE, DELAYED R...
EQ 75MG BASE/PACKE...
2020-02-14
213491
PROCYSBI
RX
Yes
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GRANULE, DELAYED R...
EQ 300MG BASE/PACK...
2020-02-14
213491
PROCYSBI
RX
Yes
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SOLUTION; TOPICAL
2%
2014-01-16
204623
PENNSAID
RX
Yes
AB
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TABLET, DELAYED RE...
EQ 20MG BASE;500MG...
2010-04-30
22511
VIMOVO
DISCN
Yes
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TABLET, DELAYED RE...
EQ 20MG BASE;375MG...
2010-04-30
22511
VIMOVO
DISCN
Yes
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TABLET; ORAL
26.6MG;800MG
2011-04-23
22519
DUEXIS
DISCN
Yes
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LIQUID; ORAL
1.1GM/ML
2013-02-01
203284
RAVICTI
RX
Yes
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VIAL; SINGLE-USE
100UG/0.5ML
103836
ACTIMMUNE
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