Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.