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Approved Drug Products containing 203985 listed in the FDA Orange Book. Original Data : FDA Website

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01 NOVARTIS PHARM (3)

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01 TABLET, FOR SUSPENSION;ORAL (3)

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01 RX (3)

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01 AFINITOR DISPERZ (3)

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01 Yes (3)

URL Supplier Web Content
TABLET, FOR SUSPEN...
5MG
2012-08-29
203985
AFINITOR DISPERZ
RX
Yes
AB
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URL Supplier Web Content
TABLET, FOR SUSPEN...
2MG
2012-08-29
203985
AFINITOR DISPERZ
RX
Yes
AB
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URL Supplier Web Content
TABLET, FOR SUSPEN...
3MG
2012-08-29
203985
AFINITOR DISPERZ
RX
Yes
AB
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PHARMACOMPASS
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your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 203985

Looking for FDA Orange Book APPLICATION 203985 3

19

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is EVEROLIMUS, with a corresponding application number 203985.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET, FOR SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 2012-08-29

Therapeutic Equivalence (TE) Code AB

18

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is EVEROLIMUS, with a corresponding application number 203985.

Regulatory Information RX

With a dosage strength 2MG

Dosage Form Route TABLET, FOR SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 2012-08-29

Therapeutic Equivalence (TE) Code AB

17

Novartis Pharmaceuticals Corporation, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is EVEROLIMUS, with a corresponding application number 203985.

Regulatory Information RX

With a dosage strength 3MG

Dosage Form Route TABLET, FOR SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 2012-08-29

Therapeutic Equivalence (TE) Code AB

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