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Approved Drug Products containing 79075 listed in the FDA Orange Book. Original Data : FDA Website

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01 WATSON LABS (5)

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01 TABLET;BUCCAL, SUBLINGUAL (5)

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01 DISCN (5)

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01 FENTANYL CITRATE (5)

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01 No (5)

URL Supplier Web Content
TABLET; BUCCAL, SU...
EQ 0.6MG BASE
2011-01-07
79075
FENTANYL CITRATE
DISCN
No
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URL Supplier Web Content
TABLET; BUCCAL, SU...
EQ 0.2MG BASE
2011-01-07
79075
FENTANYL CITRATE
DISCN
No
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TABLET; BUCCAL, SU...
EQ 0.8MG BASE
2011-01-07
79075
FENTANYL CITRATE
DISCN
No
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TABLET; BUCCAL, SU...
EQ 0.4MG BASE
2011-01-07
79075
FENTANYL CITRATE
DISCN
No
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TABLET; BUCCAL, SU...
EQ 0.1MG BASE
2011-01-07
79075
FENTANYL CITRATE
DISCN
No
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Looking for FDA Orange Book APPLICATION 79075

Looking for FDA Orange Book APPLICATION 79075 5

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 FENTANYL CITRATE, with a corresponding application number 79075.

Regulatory Information DISCN

With a dosage strength EQ 0.6MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug No

Approved since 2011-01-07

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 FENTANYL CITRATE, with a corresponding application number 79075.

Regulatory Information DISCN

With a dosage strength EQ 0.2MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug No

Approved since 2011-01-07

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 FENTANYL CITRATE, with a corresponding application number 79075.

Regulatory Information DISCN

With a dosage strength EQ 0.8MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug No

Approved since 2011-01-07

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 FENTANYL CITRATE, with a corresponding application number 79075.

Regulatory Information DISCN

With a dosage strength EQ 0.4MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug No

Approved since 2011-01-07

15

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 FENTANYL CITRATE, with a corresponding application number 79075.

Regulatory Information DISCN

With a dosage strength EQ 0.1MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug No

Approved since 2011-01-07

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