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Approved Drug Products containing 91414 listed in the FDA Orange Book. Original Data : FDA Website

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01 SANDOZ INC (2)

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01 TABLET, CHEWABLE;ORAL (2)

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01 RX (2)

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01 MONTELUKAST SODIUM (2)

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01 No (2)

URL Supplier Web Content
TABLET, CHEWABLE; ...
EQ 4MG BASE
2012-08-03
91414
MONTELUKAST SODIUM
RX
No
AB
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URL Supplier Web Content
TABLET, CHEWABLE; ...
EQ 5MG BASE
2012-08-03
91414
MONTELUKAST SODIUM
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 91414

Looking for FDA Orange Book APPLICATION 91414 2

19

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 91414.

Regulatory Information RX

With a dosage strength EQ 4MG BASE

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2012-08-03

Therapeutic Equivalence (TE) Code AB

18

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 91414.

Regulatory Information RX

With a dosage strength EQ 5MG BASE

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2012-08-03

Therapeutic Equivalence (TE) Code AB

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