Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091502

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TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Discontinued

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: 
Application Number: A091502
Product Number: 001
Approval Date: Nov 9, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Discontinued

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: 
Application Number: A091502
Product Number: 002
Approval Date: Nov 9, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
EQ 6MG BASE
Marketing Status: Discontinued

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: 
Application Number: A091502
Product Number: 003
Approval Date: Nov 9, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information