FDA Approval Activities for this Drug…

Hytrin (terazosin HCl) 1, 2, 5 and 10 mg Tablets (NDA 19-057) & Hytrin (terazosin HCl) 1, 2, 5 and 10 mg Soft Elastic Capsules (NDA 20-347). Abbott NDA 19-057/S15 & 20-347/S6 Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Ranbaxy Ltd. ANDA 76-021 8/22/02 Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Invamed ANDA 75-667 7/28/00 11/7/00 Terazosin Hydrochloride Capsules,1 mg (Base), 2 mg (Base), 5 mg (Base) and 10 mg (Base), Zenith Goldline ANDA 75-614 1/30/01 3/5/01 Terazosin Hydrochloride Capsules,1 mg (Base), 2 mg (Base), 5 mg (Base) and 10 mg (Base), Torpharm ANDA 75-498 4/12/01 4/13/01 Terazosin Hydrochloride Capsules,1 mg (Base), 2 mg (Base), 5 mg (Base) and 10 mg (Base), Mylan Technologies, ANDA 75-384 12/1/00 3/6/01 Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Geneva ANDA 74-823 3/30/98 3/15/99 Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Sep. 28, 1999 Mylan ANDA 75-140 9/28/98 9/28/98 8/24/01 Terazosin Hydrochloride Capsules, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Mylan ANDA 75-140 2/11/00 2/17/00 Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Invamed, ANDA 74-657 4/28/00 4/28/00 8/5/03 Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base), and 10 mg (base), Aug. 20, 1999 Invamed, ANDA 74-657 8/20/99 8/24/99 Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) and 10 mg (base), Zenith Goldline ANDA 74-530 4/21/00 4/28/00 8/4/03 Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) and 10 mg (base), Novopharm Limited ANDA 74-446 5/18/00 5/22/00 8/4/03 Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) and 10 mg (base), Geneva ANDA 74-315 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE HYTRIN Abbott 020347 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE HYTRIN Abbott 020347 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE HYTRIN Abbott 020347 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE HYTRIN Abbott 074823 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL Geneva 074823 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL Geneva 074823 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL Geneva 074823 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL Geneva 075667 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL INVAMED 075667 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL INVAMED 075667 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL INVAMED 075667 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL INVAMED 075614 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL Ivax 075614 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL Ivax 075614 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL Ivax 075614 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL Ivax 075140 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL Mylan 075140 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL Mylan 075140 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL Mylan 075140 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL Mylan 075384 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL Mylan TECHNOLOGIES 075384 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL Mylan TECHNOLOGIES 075384 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL Mylan TECHNOLOGIES 075384 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL Mylan TECHNOLOGIES 076021 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL Ranbaxy 076021 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL Ranbaxy 076021 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL Ranbaxy 076021 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL Ranbaxy 075498 TERAZOSIN HYDROCHLORIDE Capsule; 10MG BASE TERAZOSIN HCL Torpharm 075498 TERAZOSIN HYDROCHLORIDE Capsule; 1MG BASE TERAZOSIN HCL Torpharm 075498 TERAZOSIN HYDROCHLORIDE Capsule; 2MG BASE TERAZOSIN HCL Torpharm 075498 TERAZOSIN HYDROCHLORIDE Capsule; 5MG BASE TERAZOSIN HCL Torpharm 019057 TERAZOSIN HYDROCHLORIDE Tablet; 10MG BASE HYTRIN Abbott 019057 TERAZOSIN HYDROCHLORIDE Tablet; 1MG BASE HYTRIN Abbott 019057 TERAZOSIN HYDROCHLORIDE Tablet; 2MG BASE HYTRIN Abbott 019057 TERAZOSIN HYDROCHLORIDE Tablet; 5MG BASE HYTRIN Abbott 074315 TERAZOSIN HYDROCHLORIDE Tablet; 10MG BASE TERAZOSIN HCL Geneva 074315 TERAZOSIN HYDROCHLORIDE Tablet; 1MG BASE TERAZOSIN HCL Geneva 074315 TERAZOSIN HYDROCHLORIDE Tablet; 2MG BASE TERAZOSIN HCL Geneva 074315 TERAZOSIN HYDROCHLORIDE Tablet; 5MG BASE TERAZOSIN HCL Geneva 074657 TERAZOSIN HYDROCHLORIDE Tablet; 10MG BASE TERAZOSIN HCL INVAMED 074657 TERAZOSIN HYDROCHLORIDE Tablet; 1MG BASE TERAZOSIN HCL INVAMED 074657 TERAZOSIN HYDROCHLORIDE Tablet; 2MG BASE TERAZOSIN HCL INVAMED 074657 TERAZOSIN HYDROCHLORIDE Tablet; 5MG BASE TERAZOSIN HCL INVAMED 074530 TERAZOSIN HYDROCHLORIDE Tablet; 10MG BASE TERAZOSIN HCL Ivax 074530 TERAZOSIN HYDROCHLORIDE Tablet; 1MG BASE TERAZOSIN HCL Ivax 074530 TERAZOSIN HYDROCHLORIDE Tablet; 2MG BASE TERAZOSIN HCL Ivax 074530 TERAZOSIN HYDROCHLORIDE Tablet; 5MG BASE TERAZOSIN HCL Ivax 074446 TERAZOSIN HYDROCHLORIDE Tablet; 10MG BASE TERAZOSIN HCL Teva 074446 TERAZOSIN HYDROCHLORIDE Tablet; 1MG BASE TERAZOSIN HCL Teva 074446 TERAZOSIN HYDROCHLORIDE Tablet; 2MG BASE TERAZOSIN HCL Teva 074446 TERAZOSIN HYDROCHLORIDE Tablet; 5MG BASE TERAZOSIN HCL Teva

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