Product Details for NDA 020646
GABITRIL (TIAGABINE HYDROCHLORIDE)
2MG
Marketing Status: Prescription
4MG
Marketing Status: Prescription
12MG
Marketing Status: Prescription
16MG
Marketing Status: Prescription
6MG
Marketing Status: Discontinued
8MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
20MG
Marketing Status: Discontinued
2MG
Marketing Status: Prescription
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020646
Product Number: 005
Approval Date: Apr 16, 1999
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020646
Product Number: 005
Approval Date: Apr 16, 1999
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
4MG
Marketing Status: Prescription
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020646
Product Number: 001
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020646
Product Number: 001
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
12MG
Marketing Status: Prescription
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020646
Product Number: 002
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020646
Product Number: 002
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
16MG
Marketing Status: Prescription
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020646
Product Number: 003
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020646
Product Number: 003
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Prescription
Patent and Exclusivity Information
6MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 006
Approval Date: Nov 29, 2005
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 006
Approval Date: Nov 29, 2005
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
8MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 007
Approval Date: Nov 29, 2005
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 007
Approval Date: Nov 29, 2005
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 008
Approval Date: Nov 29, 2005
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
GABITRIL (TIAGABINE HYDROCHLORIDE)
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 008
Approval Date: Nov 29, 2005
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 004
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: GABITRIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020646
Product Number: 004
Approval Date: Sep 30, 1997
Applicant Holder Full Name: CEPHALON INC
Marketing Status: Discontinued
Patent and Exclusivity Information