Product Details for ANDA 213223
TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Prescription
EQ 4MG BASE
Marketing Status: Prescription
EQ 6MG BASE
Marketing Status: Prescription
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213223
Product Number: 001
Approval Date: Jan 13, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213223
Product Number: 001
Approval Date: Jan 13, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213223
Product Number: 002
Approval Date: Jan 13, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213223
Product Number: 002
Approval Date: Jan 13, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 6MG BASE
Marketing Status: Prescription
Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213223
Product Number: 003
Approval Date: Jan 13, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213223
Product Number: 003
Approval Date: Jan 13, 2020
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information