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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076416

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TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076416
Product Number: 001
Approval Date: Sep 29, 2003
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: TIZANIDINE HYDROCHLORIDE
Proprietary Name: TIZANIDINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076416
Product Number: 002
Approval Date: Sep 29, 2003
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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