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Approved Drug Products containing 78755 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS LTD (3)

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01 TABLET, DELAYED RELEASE;ORAL (3)

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01 RX (3)

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01 DIVALPROEX SODIUM (3)

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01 No (3)

URL Supplier Web Content
TABLET, DELAYED RE...
EQ 125MG VALPROIC ...
2008-07-29
78755
DIVALPROEX SODIUM
RX
No
AB
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URL Supplier Web Content
TABLET, DELAYED RE...
EQ 250MG VALPROIC ...
2008-07-29
78755
DIVALPROEX SODIUM
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
TABLET, DELAYED RE...
EQ 500MG VALPROIC ...
2008-07-29
78755
DIVALPROEX SODIUM
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 78755

Looking for FDA Orange Book APPLICATION 78755 3

19

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIVALPROEX SODIUM, with a corresponding application number 78755.

Regulatory Information RX

With a dosage strength EQ 125MG VALPROIC ACID

Dosage Form Route TABLET, DELAYED RELEASE; ORAL

Reference Listed Drug No

Approved since 2008-07-29

Therapeutic Equivalence (TE) Code AB

18

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIVALPROEX SODIUM, with a corresponding application number 78755.

Regulatory Information RX

With a dosage strength EQ 250MG VALPROIC ACID

Dosage Form Route TABLET, DELAYED RELEASE; ORAL

Reference Listed Drug No

Approved since 2008-07-29

Therapeutic Equivalence (TE) Code AB

17

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIVALPROEX SODIUM, with a corresponding application number 78755.

Regulatory Information RX

With a dosage strength EQ 500MG VALPROIC ACID

Dosage Form Route TABLET, DELAYED RELEASE; ORAL

Reference Listed Drug No

Approved since 2008-07-29

Therapeutic Equivalence (TE) Code AB

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