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Approved Drug Products containing 78561 listed in the FDA Orange Book. Original Data : FDA Website

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01 ACTAVIS ELIZABETH (4)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (4)

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01 RX (4)

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01 ALPRAZOLAM (4)

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01 No (4)

URL Supplier Web Content
TABLET, ORALLY DIS...
2MG
2010-03-16
78561
ALPRAZOLAM
RX
No
AB
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TABLET, ORALLY DIS...
0.5MG
2010-03-16
78561
ALPRAZOLAM
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
1MG
2010-03-16
78561
ALPRAZOLAM
RX
No
AB
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TABLET, ORALLY DIS...
0.25MG
2010-03-16
78561
ALPRAZOLAM
RX
No
AB
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Looking for FDA Orange Book APPLICATION 78561

Looking for FDA Orange Book APPLICATION 78561 4

19

Actavis Inc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ALPRAZOLAM, with a corresponding application number 78561.

Regulatory Information RX

With a dosage strength 2MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2010-03-16

Therapeutic Equivalence (TE) Code AB

18

Actavis Inc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ALPRAZOLAM, with a corresponding application number 78561.

Regulatory Information RX

With a dosage strength 0.5MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2010-03-16

Therapeutic Equivalence (TE) Code AB

17

Actavis Inc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ALPRAZOLAM, with a corresponding application number 78561.

Regulatory Information RX

With a dosage strength 1MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2010-03-16

Therapeutic Equivalence (TE) Code AB

16

Actavis Inc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ALPRAZOLAM, with a corresponding application number 78561.

Regulatory Information RX

With a dosage strength 0.25MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2010-03-16

Therapeutic Equivalence (TE) Code AB

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