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Approved Drug Products containing 203858 listed in the FDA Orange Book. Original Data : FDA Website

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01 CHIESI (6)

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01 CAPSULE;ORAL (6)

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01 DISCN (2)

02 RX (4)

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01 JUXTAPID (6)

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01 Yes (6)

URL Supplier Web Content
CAPSULE; ORAL
EQ 30MG BASE
2015-04-23
203858
JUXTAPID
RX
Yes
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URL Supplier Web Content
CAPSULE; ORAL
EQ 10MG BASE
2012-12-21
203858
JUXTAPID
RX
Yes
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URL Supplier Web Content
CAPSULE; ORAL
EQ 40MG BASE
2015-04-23
203858
JUXTAPID
DISCN
Yes
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URL Supplier Web Content
CAPSULE; ORAL
EQ 20MG BASE
2012-12-21
203858
JUXTAPID
RX
Yes
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URL Supplier Web Content
CAPSULE; ORAL
EQ 5MG BASE
2012-12-21
203858
JUXTAPID
RX
Yes
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CAPSULE; ORAL
EQ 60MG BASE
2015-04-23
203858
JUXTAPID
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 203858

Looking for FDA Orange Book APPLICATION 203858 6

19

CHIESI USA INC, based in U.S.A, is a pharmaceutical company.

One of their notable products is LOMITAPIDE MESYLATE, with a corresponding application number 203858.

Regulatory Information RX

With a dosage strength EQ 30MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2015-04-23

18

CHIESI USA INC, based in U.S.A, is a pharmaceutical company.

One of their notable products is LOMITAPIDE MESYLATE, with a corresponding application number 203858.

Regulatory Information RX

With a dosage strength EQ 10MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-12-21

17

CHIESI USA INC, based in U.S.A, is a pharmaceutical company.

One of their notable products is LOMITAPIDE MESYLATE, with a corresponding application number 203858.

Regulatory Information DISCN

With a dosage strength EQ 40MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2015-04-23

16

CHIESI USA INC, based in U.S.A, is a pharmaceutical company.

One of their notable products is LOMITAPIDE MESYLATE, with a corresponding application number 203858.

Regulatory Information RX

With a dosage strength EQ 20MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-12-21

15

CHIESI USA INC, based in U.S.A, is a pharmaceutical company.

One of their notable products is LOMITAPIDE MESYLATE, with a corresponding application number 203858.

Regulatory Information RX

With a dosage strength EQ 5MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2012-12-21

14

CHIESI USA INC, based in U.S.A, is a pharmaceutical company.

One of their notable products is LOMITAPIDE MESYLATE, with a corresponding application number 203858.

Regulatory Information DISCN

With a dosage strength EQ 60MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2015-04-23

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