CEPHALON INC
FDA Approved Drugs
CEPHALON INC
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 31
- Latest Approval Date Oct 13, 2017
- Data Source FDA
- First Approval Date Oct 04, 1993
Company Snapshot
FDA Approved Drug Records ( 31 records )
Drug Name
ACTIQ
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Active Ingredient
FENTANYL CITRATE
Application Number
20747
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Regulatory Status
Discontinued
Drug Name
ACTIQ
Product Number
2
Dosage Form
-
Strength
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Active Ingredient
FENTANYL CITRATE
Application Number
20747
Product Number
2
Dosage Form
-
Strength
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Regulatory Status
Discontinued
Drug Name
ACTIQ
Product Number
3
Dosage Form
-
Strength
EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Active Ingredient
FENTANYL CITRATE
Application Number
20747
Product Number
3
Dosage Form
-
Strength
EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Regulatory Status
Discontinued
Drug Name
ACTIQ
Product Number
4
Dosage Form
-
Strength
EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Active Ingredient
FENTANYL CITRATE
Application Number
20747
Product Number
4
Dosage Form
-
Strength
EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Regulatory Status
Discontinued
Drug Name
ACTIQ
Product Number
5
Dosage Form
-
Strength
EQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Active Ingredient
FENTANYL CITRATE
Application Number
20747
Product Number
5
Dosage Form
-
Strength
EQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Regulatory Status
Discontinued
Drug Name
ACTIQ
Product Number
6
Dosage Form
-
Strength
EQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Active Ingredient
FENTANYL CITRATE
Application Number
20747
Product Number
6
Dosage Form
-
Strength
EQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-11-04
Regulatory Status
Discontinued
Drug Name
FENTANYL
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE
Approval Date
1993-10-04
Active Ingredient
FENTANYL CITRATE
Application Number
20195
Product Number
1
Dosage Form
-
Strength
EQ 0.2MG BASE
Approval Date
1993-10-04
Regulatory Status
Discontinued
Drug Name
FENTANYL
Product Number
2
Dosage Form
-
Strength
EQ 0.3MG BASE
Approval Date
1993-10-04
Active Ingredient
FENTANYL CITRATE
Application Number
20195
Product Number
2
Dosage Form
-
Strength
EQ 0.3MG BASE
Approval Date
1993-10-04
Regulatory Status
Discontinued
Drug Name
FENTANYL
Product Number
3
Dosage Form
-
Strength
EQ 0.4MG BASE
Approval Date
1993-10-04
Active Ingredient
FENTANYL CITRATE
Application Number
20195
Product Number
3
Dosage Form
-
Strength
EQ 0.4MG BASE
Approval Date
1993-10-04
Regulatory Status
Discontinued
Drug Name
FENTANYL
Product Number
7
Dosage Form
-
Strength
EQ 0.1MG BASE
Approval Date
1995-10-30
Active Ingredient
FENTANYL CITRATE
Application Number
20195
Product Number
7
Dosage Form
-
Strength
EQ 0.1MG BASE
Approval Date
1995-10-30
Regulatory Status
Discontinued
Drug Name
FENTORA
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Active Ingredient
FENTANYL CITRATE
Application Number
21947
Product Number
1
Dosage Form
-
Strength
EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Regulatory Status
Discontinued
Drug Name
FENTORA
Product Number
2
Dosage Form
-
Strength
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Active Ingredient
FENTANYL CITRATE
Application Number
21947
Product Number
2
Dosage Form
-
Strength
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Regulatory Status
Discontinued
Drug Name
FENTORA
Product Number
3
Dosage Form
-
Strength
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Active Ingredient
FENTANYL CITRATE
Application Number
21947
Product Number
3
Dosage Form
-
Strength
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Regulatory Status
Discontinued
Drug Name
FENTORA
Product Number
4
Dosage Form
-
Strength
EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Active Ingredient
FENTANYL CITRATE
Application Number
21947
Product Number
4
Dosage Form
-
Strength
EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Regulatory Status
Discontinued
Drug Name
FENTORA
Product Number
5
Dosage Form
-
Strength
EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Active Ingredient
FENTANYL CITRATE
Application Number
21947
Product Number
5
Dosage Form
-
Strength
EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2006-09-25
Regulatory Status
Discontinued
Drug Name
FENTORA
Product Number
6
Dosage Form
-
Strength
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-03-02
Active Ingredient
FENTANYL CITRATE
Application Number
21947
Product Number
6
Dosage Form
-
Strength
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2007-03-02
Regulatory Status
Discontinued
Drug Name
GABITRIL
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1997-09-30
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1997-09-30
Regulatory Status
RX
Drug Name
GABITRIL
Product Number
2
Dosage Form
-
Strength
12MG
Approval Date
1997-09-30
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
2
Dosage Form
-
Strength
12MG
Approval Date
1997-09-30
Regulatory Status
RX
Drug Name
GABITRIL
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
1997-09-30
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
1997-09-30
Regulatory Status
RX
Drug Name
GABITRIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
1997-09-30
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
1997-09-30
Regulatory Status
Discontinued
Drug Name
GABITRIL
Product Number
5
Dosage Form
-
Strength
2MG
Approval Date
1999-04-16
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
5
Dosage Form
-
Strength
2MG
Approval Date
1999-04-16
Regulatory Status
RX
Drug Name
GABITRIL
Product Number
6
Dosage Form
-
Strength
6MG
Approval Date
2005-11-29
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
6
Dosage Form
-
Strength
6MG
Approval Date
2005-11-29
Regulatory Status
Discontinued
Drug Name
GABITRIL
Product Number
7
Dosage Form
-
Strength
8MG
Approval Date
2005-11-29
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
7
Dosage Form
-
Strength
8MG
Approval Date
2005-11-29
Regulatory Status
Discontinued
Drug Name
GABITRIL
Product Number
8
Dosage Form
-
Strength
10MG
Approval Date
2005-11-29
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
20646
Product Number
8
Dosage Form
-
Strength
10MG
Approval Date
2005-11-29
Regulatory Status
Discontinued
Drug Name
TREANDA
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2008-03-20
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
22249
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2008-03-20
Regulatory Status
RX
Drug Name
TREANDA
Product Number
2
Dosage Form
-
Strength
25MG/VIAL
Approval Date
2009-05-01
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
22249
Product Number
2
Dosage Form
-
Strength
25MG/VIAL
Approval Date
2009-05-01
Regulatory Status
RX
Drug Name
TREANDA
Product Number
3
Dosage Form
-
Strength
45MG/0.5ML (90MG/ML)
Approval Date
2013-09-13
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
22249
Product Number
3
Dosage Form
-
Strength
45MG/0.5ML (90MG/ML)
Approval Date
2013-09-13
Regulatory Status
Discontinued
Drug Name
TREANDA
Product Number
4
Dosage Form
-
Strength
180MG/2ML (90MG/ML)
Approval Date
2013-09-13
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
22249
Product Number
4
Dosage Form
-
Strength
180MG/2ML (90MG/ML)
Approval Date
2013-09-13
Regulatory Status
Discontinued
Drug Name
TREANDA
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Application Number
22303
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TRISENOX
Product Number
1
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-09-25
Active Ingredient
ARSENIC TRIOXIDE
Application Number
21248
Product Number
1
Dosage Form
-
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-09-25
Regulatory Status
Discontinued
Drug Name
TRISENOX
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-10-13
Active Ingredient
ARSENIC TRIOXIDE
Application Number
21248
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-10-13
Regulatory Status
RX
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Drug Status Breakdown
31 total- Discontinued
- RX
- Unclassified
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Explore important FDA approved drug information available in the records above.
Drug Name
ACTIQ
Application Number
20747
Product Number
1
Active Ingredient
FENTANYL CITRATE
Dosage Form
-
Strength
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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