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Approved Drug Products containing 201635 listed in the FDA Orange Book. Original Data : FDA Website

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01 SUPERNUS PHARMS (4)

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01 CAPSULE, EXTENDED RELEASE;ORAL (4)

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01 RX (4)

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01 TROKENDI XR (4)

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01 Yes (4)

URL Supplier Web Content
CAPSULE, EXTENDED ...
200MG
2013-08-16
201635
TROKENDI XR
RX
Yes
AB1
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CAPSULE, EXTENDED ...
50MG
2013-08-16
201635
TROKENDI XR
RX
Yes
AB1
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CAPSULE, EXTENDED ...
100MG
2013-08-16
201635
TROKENDI XR
RX
Yes
AB1
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CAPSULE, EXTENDED ...
25MG
2013-08-16
201635
TROKENDI XR
RX
Yes
AB1
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Looking for FDA Orange Book APPLICATION 201635

Looking for FDA Orange Book APPLICATION 201635 4

19

Supernus Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is TOPIRAMATE, with a corresponding application number 201635.

Regulatory Information RX

With a dosage strength 200MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-08-16

Therapeutic Equivalence (TE) Code AB1

18

Supernus Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is TOPIRAMATE, with a corresponding application number 201635.

Regulatory Information RX

With a dosage strength 50MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-08-16

Therapeutic Equivalence (TE) Code AB1

17

Supernus Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is TOPIRAMATE, with a corresponding application number 201635.

Regulatory Information RX

With a dosage strength 100MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-08-16

Therapeutic Equivalence (TE) Code AB1

16

Supernus Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is TOPIRAMATE, with a corresponding application number 201635.

Regulatory Information RX

With a dosage strength 25MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-08-16

Therapeutic Equivalence (TE) Code AB1

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