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Approved Drug Products containing 205122 listed in the FDA Orange Book. Original Data : FDA Website

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01 UPSHER SMITH LABS (5)

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01 CAPSULE, EXTENDED RELEASE;ORAL (5)

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01 RX (5)

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01 QUDEXY XR (5)

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01 Yes (5)

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CAPSULE, EXTENDED ...
200MG
2014-03-11
205122
QUDEXY XR
RX
Yes
AB2
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CAPSULE, EXTENDED ...
100MG
2014-03-11
205122
QUDEXY XR
RX
Yes
AB2
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CAPSULE, EXTENDED ...
25MG
2014-03-11
205122
QUDEXY XR
RX
Yes
AB2
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CAPSULE, EXTENDED ...
150MG
2014-03-11
205122
QUDEXY XR
RX
Yes
AB2
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CAPSULE, EXTENDED ...
50MG
2014-03-11
205122
QUDEXY XR
RX
Yes
AB2
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Looking for FDA Orange Book APPLICATION 205122

Looking for FDA Orange Book APPLICATION 205122 5

19

Upsher-Smith Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TOPIRAMATE, with a corresponding application number 205122.

Regulatory Information RX

With a dosage strength 200MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-03-11

Therapeutic Equivalence (TE) Code AB2

18

Upsher-Smith Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TOPIRAMATE, with a corresponding application number 205122.

Regulatory Information RX

With a dosage strength 100MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-03-11

Therapeutic Equivalence (TE) Code AB2

17

Upsher-Smith Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TOPIRAMATE, with a corresponding application number 205122.

Regulatory Information RX

With a dosage strength 25MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-03-11

Therapeutic Equivalence (TE) Code AB2

16

Upsher-Smith Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TOPIRAMATE, with a corresponding application number 205122.

Regulatory Information RX

With a dosage strength 150MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-03-11

Therapeutic Equivalence (TE) Code AB2

15

Upsher-Smith Laboratories, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TOPIRAMATE, with a corresponding application number 205122.

Regulatory Information RX

With a dosage strength 50MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-03-11

Therapeutic Equivalence (TE) Code AB2

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