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Approved Drug Products containing 21350 listed in the FDA Orange Book. Original Data : FDA Website

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01 SKYEPHARMA AG (2)

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01 TABLET;ORAL (2)

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01 DISCN (1)

02 RX (1)

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01 TRIGLIDE (2)

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01 No (1)

02 Yes (1)

URL Supplier Web Content
TABLET; ORAL
160MG
2005-05-07
21350
TRIGLIDE
RX
Yes
BX
URL Supplier Web Content
TABLET; ORAL
50MG
2005-05-07
21350
TRIGLIDE
DISCN
No

Looking for FDA Orange Book APPLICATION 21350

Looking for FDA Orange Book APPLICATION 21350 2

19

Skyepharma, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Skyepharma, an Expert and Agile CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

One of their notable products is FENOFIBRATE, with a corresponding application number 21350.

Regulatory Information RX

With a dosage strength 160MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2005-05-07

Therapeutic Equivalence (TE) Code BX

18

Skyepharma, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Skyepharma, an Expert and Agile CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

One of their notable products is FENOFIBRATE, with a corresponding application number 21350.

Regulatory Information DISCN

With a dosage strength 50MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2005-05-07

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