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Approved Drug Products containing 76921 listed in the FDA Orange Book. Original Data : FDA Website

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01 AUROBINDO (4)

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01 TABLET;ORAL (4)

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01 RX (4)

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01 MIRTAZAPINE (4)

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01 No (4)

URL Supplier Web Content
TABLET; ORAL
7.5MG
2004-10-22
76921
MIRTAZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
45MG
2004-10-22
76921
MIRTAZAPINE
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
15MG
2004-10-22
76921
MIRTAZAPINE
RX
No
AB
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TABLET; ORAL
30MG
2004-10-22
76921
MIRTAZAPINE
RX
No
AB
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Looking for FDA Orange Book APPLICATION 76921

Looking for FDA Orange Book APPLICATION 76921 4

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 76921.

Regulatory Information RX

With a dosage strength 7.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-10-22

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 76921.

Regulatory Information RX

With a dosage strength 45MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-10-22

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 76921.

Regulatory Information RX

With a dosage strength 15MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-10-22

Therapeutic Equivalence (TE) Code AB

16

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 76921.

Regulatory Information RX

With a dosage strength 30MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2004-10-22

Therapeutic Equivalence (TE) Code AB

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