Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 091502

Expand all

TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
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: A091502
Product Number: 001
Approval Date: Nov 9, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS 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: CAPSULE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091502
Product Number: 002
Approval Date: Nov 9, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TIZANIDINE HYDROCHLORIDE (TIZANIDINE HYDROCHLORIDE)
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: A091502
Product Number: 003
Approval Date: Nov 9, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English