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Approved Drug Products containing 22115 listed in the FDA Orange Book. Original Data : FDA Website

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01 GLAXOSMITHKLINE LLC (6)

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01 TABLET, EXTENDED RELEASE;ORAL (6)

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01 RX (6)

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01 LAMICTAL XR (6)

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01 Yes (6)

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  • FDA
  • EDQM
  • WHO-GMP
URL Supplier Web Content
TABLET, EXTENDED R...
250MG
2011-06-21
22115
LAMICTAL XR
RX
Yes
AB
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  • FDA
  • EDQM
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TABLET, EXTENDED R...
200MG
2009-05-29
22115
LAMICTAL XR
RX
Yes
AB
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  • FDA
  • EDQM
  • WHO-GMP
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TABLET, EXTENDED R...
50MG
2009-05-29
22115
LAMICTAL XR
RX
Yes
AB
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TABLET, EXTENDED R...
300MG
2010-04-14
22115
LAMICTAL XR
RX
Yes
AB
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  • FDA
  • EDQM
  • WHO-GMP
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TABLET, EXTENDED R...
100MG
2009-05-29
22115
LAMICTAL XR
RX
Yes
AB
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  • FDA
  • EDQM
  • WHO-GMP
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TABLET, EXTENDED R...
25MG
2009-05-29
22115
LAMICTAL XR
RX
Yes
AB
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Looking for FDA Orange Book APPLICATION 22115

Looking for FDA Orange Book APPLICATION 22115 6

19

GSK, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LAMOTRIGINE, with a corresponding application number 22115.

Regulatory Information RX

With a dosage strength 250MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-06-21

Therapeutic Equivalence (TE) Code AB

18

GSK, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LAMOTRIGINE, with a corresponding application number 22115.

Regulatory Information RX

With a dosage strength 200MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2009-05-29

Therapeutic Equivalence (TE) Code AB

17

GSK, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LAMOTRIGINE, with a corresponding application number 22115.

Regulatory Information RX

With a dosage strength 50MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2009-05-29

Therapeutic Equivalence (TE) Code AB

16

GSK, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LAMOTRIGINE, with a corresponding application number 22115.

Regulatory Information RX

With a dosage strength 300MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2010-04-14

Therapeutic Equivalence (TE) Code AB

15

GSK, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LAMOTRIGINE, with a corresponding application number 22115.

Regulatory Information RX

With a dosage strength 100MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2009-05-29

Therapeutic Equivalence (TE) Code AB

14

GSK, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is LAMOTRIGINE, with a corresponding application number 22115.

Regulatory Information RX

With a dosage strength 25MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2009-05-29

Therapeutic Equivalence (TE) Code AB

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