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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214816

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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: A214816
Product Number: 001
Approval Date: Nov 16, 2021
Applicant Holder Full Name: MSN LABORATORIES PRIVATE 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: A214816
Product Number: 002
Approval Date: Nov 16, 2021
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
12MG
Marketing Status: Prescription
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: AB
Application Number: A214816
Product Number: 003
Approval Date: Nov 16, 2021
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
16MG
Marketing Status: Prescription
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: AB
Application Number: A214816
Product Number: 004
Approval Date: Nov 16, 2021
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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