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Athena Athena

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Approved Drug Products containing 8762 listed in the FDA Orange Book. Original Data : FDA Website

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01 VIATRIS (2)

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01 SUSPENSION;ORAL (2)

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01 DISCN (1)

02 RX (1)

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01 DILANTIN-125 (1)

02 DILANTIN-30 (1)

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01 No (1)

02 Yes (1)

URL Supplier Web Content
SUSPENSION; ORAL
125MG/5ML
1982-01-01
8762
DILANTIN-125
RX
Yes
AB
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URL Supplier Web Content
SUSPENSION; ORAL
30MG/5ML
1982-01-01
8762
DILANTIN-30
DISCN
No
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US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 8762

Looking for FDA Orange Book APPLICATION 8762 2

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 PHENYTOIN, with a corresponding application number 8762.

Regulatory Information RX

With a dosage strength 125MG/5ML

Dosage Form Route SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

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 PHENYTOIN, with a corresponding application number 8762.

Regulatory Information DISCN

With a dosage strength 30MG/5ML

Dosage Form Route SUSPENSION; ORAL

Reference Listed Drug No

Approved since 1982-01-01

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