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Approved Drug Products containing 91128 listed in the FDA Orange Book. Original Data : FDA Website

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01 HIKMA (2)

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01 TABLET, CHEWABLE;ORAL (2)

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01 DISCN (2)

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01 MONTELUKAST SODIUM (2)

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01 No (2)

URL Supplier Web Content
TABLET, CHEWABLE; ...
EQ 5MG BASE
2012-08-03
91128
MONTELUKAST SODIUM
DISCN
No
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URL Supplier Web Content
TABLET, CHEWABLE; ...
EQ 4MG BASE
2012-08-03
91128
MONTELUKAST SODIUM
DISCN
No
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 91128

Looking for FDA Orange Book APPLICATION 91128 2

19

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 91128.

Regulatory Information DISCN

With a dosage strength EQ 5MG BASE

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2012-08-03

18

Hikma Pharmaceuticals, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 91128.

Regulatory Information DISCN

With a dosage strength EQ 4MG BASE

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2012-08-03

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