01 1INDAPAMIDE
02 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FRESONARA, ITALY.
03 1PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE
04 1TERAZOSIN HCI. 2H20 BULK SUBSTANCE
05 1TERAZOSIN HCL 2H20
06 1TERAZOSIN HCL. 2H2O
07 1TORSEMIDE (MOD 1) BULK SUBSTANCE
01 2BIOINDUSTRIA FARMACEUTICI SPA
02 5BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA
01 7Italy
01 4Active
02 3Inactive
01 2Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9026
Submission : 1991-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-27
Pay. Date : 2017-12-11
DMF Number : 15321
Submission : 2001-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12424
Submission : 1997-03-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12802
Submission : 1997-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-08
Pay. Date : 2022-10-21
DMF Number : 14916
Submission : 2000-06-12
Status : Active
Type : II
