FDA Approval Activities for this Drug…

Tizanidine Capsules, 2, 4 & 6 mg, Elan NDA 21-447 8/29/02 9/12/02 8/30/02 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Caraco Pharmaceutical ANDA 76-416 9/29/03 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Corepharma ANDA 76-347 10/11/02 Tizanidine Hydrochloride Tablets, 2 mg (base), Eon Labs, ANDA 76-399 11/26/02 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Barr, ANDA 76-371 4/9/03 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Mylan ANDA 76-354 3/28/03 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Dr. Reddy's Ltd. ANDA 76-286 7/3/02 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Amide Pharmaceutical ANDA 76-281 10/20/03 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Teva ANDA 76-284 7/3/02 Tizanidine Hydrochloride Tablets, 2 & 4 mg (base), Purepac Pharmaceutical ANDA 76-283 7/12/02 Tizanidine Hydrochloride Tablets, 4 mg (base), Eon Labs, ANDA 76-280 Zanaflex (tizanidine) Tablets, 2 mg and 4 mg, Elan NDA 20-397/S-014 Tizanidine Hydrochloride Tablets, Amide Pharmaceutical TIZANIDINE HYDROCHLORIDE Capsule; 2MG BASE ZANAFLEX ELAN 021447 TIZANIDINE HYDROCHLORIDE Capsule; 4MG BASE ZANAFLEX ELAN 021447 TIZANIDINE HYDROCHLORIDE Capsule; 6MG BASE ZANAFLEX ELAN 076371 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Barr 076371 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Barr 076416 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Caraco 076416 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Caraco 076347 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Corepharma 076347 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Corepharma 076286 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL DR REDDYS INC 076286 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL DR REDDYS INC 020397 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE ZANAFLEX ELAN 020397 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE ZANAFLEX ELAN 076399 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Eon 076280 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Eon 076354 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Mylan 076354 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Mylan 076283 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Purepac 076283 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Purepac 076284 TIZANIDINE HYDROCHLORIDE Tablet; 2MG BASE TIZANIDINE HCL Teva 076284 TIZANIDINE HYDROCHLORIDE Tablet; 4MG BASE TIZANIDINE HCL Teva Tizanidine Hydrochloride Tablets, Alphapharm Tizanidine Hydrochloride Tablets, TorPharm, Inc. | Tizanidine Hydrochloride Tablets, Ivax Pharma, Approval

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