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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077555

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TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
2MG
Marketing Status: Prescription
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: AB
Application Number: A077555
Product Number: 001
Approval Date: Nov 4, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
4MG
Marketing Status: Prescription
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: AB
Application Number: A077555
Product Number: 002
Approval Date: Nov 4, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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