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Approved Drug Products containing 91265 listed in the FDA Orange Book. Original Data : FDA Website

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01 APOTEX INC (4)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (4)

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01 RX (4)

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01 OLANZAPINE (4)

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01 No (4)

URL Supplier Web Content
TABLET, ORALLY DIS...
10MG
2011-10-24
91265
OLANZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
15MG
2011-10-24
91265
OLANZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
5MG
2011-10-24
91265
OLANZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
20MG
2011-10-24
91265
OLANZAPINE
RX
No
AB
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PHARMACOMPASS
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Looking for FDA Orange Book APPLICATION 91265

Looking for FDA Orange Book APPLICATION 91265 4

19

Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is OLANZAPINE, with a corresponding application number 91265.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2011-10-24

Therapeutic Equivalence (TE) Code AB

18

Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is OLANZAPINE, with a corresponding application number 91265.

Regulatory Information RX

With a dosage strength 15MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2011-10-24

Therapeutic Equivalence (TE) Code AB

17

Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is OLANZAPINE, with a corresponding application number 91265.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2011-10-24

Therapeutic Equivalence (TE) Code AB

16

Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is OLANZAPINE, with a corresponding application number 91265.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2011-10-24

Therapeutic Equivalence (TE) Code AB

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