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Approved Drug Products containing 77376 listed in the FDA Orange Book. Original Data : FDA Website

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01 AUROBINDO PHARMA (3)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (3)

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01 RX (3)

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01 MIRTAZAPINE (3)

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01 No (3)

URL Supplier Web Content
TABLET, ORALLY DIS...
45MG
2006-02-28
77376
MIRTAZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
15MG
2005-12-08
77376
MIRTAZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
30MG
2005-12-08
77376
MIRTAZAPINE
RX
No
AB
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PHARMACOMPASS
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your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 77376

Looking for FDA Orange Book APPLICATION 77376 3

19

Aurobindo Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is MIRTAZAPINE, with a corresponding application number 77376.

Regulatory Information RX

With a dosage strength 45MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2006-02-28

Therapeutic Equivalence (TE) Code AB

18

Aurobindo Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is MIRTAZAPINE, with a corresponding application number 77376.

Regulatory Information RX

With a dosage strength 15MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2005-12-08

Therapeutic Equivalence (TE) Code AB

17

Aurobindo Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is MIRTAZAPINE, with a corresponding application number 77376.

Regulatory Information RX

With a dosage strength 30MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2005-12-08

Therapeutic Equivalence (TE) Code AB

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