Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021447

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ZANAFLEX (TIZANIDINE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Prescription

Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: ZANAFLEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021447
Product Number: 001
Approval Date: Aug 29, 2002
Applicant Holder Full Name: LEGACY PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZANAFLEX (TIZANIDINE HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: ZANAFLEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021447
Product Number: 002
Approval Date: Aug 29, 2002
Applicant Holder Full Name: LEGACY PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZANAFLEX (TIZANIDINE HYDROCHLORIDE)
EQ 6MG BASE
Marketing Status: Prescription

Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: ZANAFLEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 6MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021447
Product Number: 003
Approval Date: Aug 29, 2002
Applicant Holder Full Name: LEGACY PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information