Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Zanaflex (Tizanidine) Tablets, Acorda Therapeutics, Labeling Revision | Zanaflex (Tizanidine) Capsules, Acorda Therapeutics, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com