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Approved Drug Products containing 76520 listed in the FDA Orange Book. Original Data : FDA Website

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01 MYLAN (3)

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01 TABLET;ORAL (3)

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01 DISCN (1)

02 RX (2)

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01 FENOFIBRATE (3)

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01 No (3)

URL Supplier Web Content
TABLET; ORAL
160MG
2007-10-25
76520
FENOFIBRATE
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
54MG
2007-10-25
76520
FENOFIBRATE
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
107MG
2005-12-29
76520
FENOFIBRATE
DISCN
No
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Looking for FDA Orange Book APPLICATION 76520

Looking for FDA Orange Book APPLICATION 76520 3

19

Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is FENOFIBRATE, with a corresponding application number 76520.

Regulatory Information RX

With a dosage strength 160MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2007-10-25

Therapeutic Equivalence (TE) Code AB

18

Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is FENOFIBRATE, with a corresponding application number 76520.

Regulatory Information RX

With a dosage strength 54MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2007-10-25

Therapeutic Equivalence (TE) Code AB

17

Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is FENOFIBRATE, with a corresponding application number 76520.

Regulatory Information DISCN

With a dosage strength 107MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2005-12-29

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