Product Details for ANDA 208181
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
2MG
Marketing Status: Discontinued
4MG
Marketing Status: Discontinued
12MG
Marketing Status: Discontinued
16MG
Marketing Status: Discontinued
2MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 001
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 001
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
4MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 002
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 002
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
12MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 003
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 003
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
16MG
Marketing Status: Discontinued
Active Ingredient: TIAGABINE HYDROCHLORIDE
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 004
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TIAGABINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 16MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A208181
Product Number: 004
Approval Date: Dec 8, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS CO GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information