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Approved Drug Products containing 21947 listed in the FDA Orange Book. Original Data : FDA Website

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01 CEPHALON (6)

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01 TABLET;BUCCAL, SUBLINGUAL (6)

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01 DISCN (1)

02 RX (5)

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01 FENTORA (6)

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01 Yes (6)

URL Supplier Web Content
TABLET; BUCCAL, SU...
EQ 0.3MG BASE **Fe...
2007-03-02
21947
FENTORA
DISCN
Yes
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TABLET; BUCCAL, SU...
EQ 0.6MG BASE
2006-09-25
21947
FENTORA
RX
Yes
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TABLET; BUCCAL, SU...
EQ 0.2MG BASE
2006-09-25
21947
FENTORA
RX
Yes
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TABLET; BUCCAL, SU...
EQ 0.8MG BASE
2006-09-25
21947
FENTORA
RX
Yes
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TABLET; BUCCAL, SU...
EQ 0.4MG BASE
2006-09-25
21947
FENTORA
RX
Yes
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TABLET; BUCCAL, SU...
EQ 0.1MG BASE
2006-09-25
21947
FENTORA
RX
Yes
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Looking for FDA Orange Book APPLICATION 21947

Looking for FDA Orange Book APPLICATION 21947 6

19

CEPHALON INC, based in U.S.A, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 21947.

Regulatory Information DISCN

With a dosage strength EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2007-03-02

18

CEPHALON INC, based in U.S.A, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 21947.

Regulatory Information RX

With a dosage strength EQ 0.6MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2006-09-25

17

CEPHALON INC, based in U.S.A, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 21947.

Regulatory Information RX

With a dosage strength EQ 0.2MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2006-09-25

16

CEPHALON INC, based in U.S.A, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 21947.

Regulatory Information RX

With a dosage strength EQ 0.8MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2006-09-25

15

CEPHALON INC, based in U.S.A, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 21947.

Regulatory Information RX

With a dosage strength EQ 0.4MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2006-09-25

14

CEPHALON INC, based in U.S.A, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is FENTANYL CITRATE, with a corresponding application number 21947.

Regulatory Information RX

With a dosage strength EQ 0.1MG BASE

Dosage Form Route TABLET; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2006-09-25

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