01 1ACEBUTOLOL HYDROCHLORIDE
02 1ALBUTEROL SULFATE
03 1BETAXOLOL HYDROCHLORIDE
04 1CARTEOLOL HYDROCHLORIDE
05 1CLONIDINE HYDROCHLORIDE
06 1DILTIAZEM HYDROCHLORIDE
07 1DILUTED ISOSORBIDE DINITRATE
08 1FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES
09 1FORMOTEROL FUMARATE DIHYDRATE
10 1GLIBENCLAMIDE (GLYBURIDE)
11 1IPRATROPIUM BROMIDE
12 1ISOXSUPRINE HYDROCHLORIDE
13 1METAPROTERENOL SULFATE
14 1NICARDIPINE HYDROCHLORIDE
15 1NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE)
16 1NIMODIPINE
17 1NISOLDIPINE
18 1OXYMETAZOLINE HCL USP XX
19 1PINDOLOL
20 1PRODUCTION AND CONTROL METHODS FOR THE
21 1PROPRANOLOL HYDROCHLORIDE USP XX, NF XV
22 1RITODRINE HYDROCHLORIDE
23 1SILVER SULFADIAZINE
24 1TERBUTALINE SULPHATE
25 1TOLNAFTATE USP XX
26 1XYLOMETAZOLINNE HYDROCHLORIDE
01 26LUSOCHIMICA SPA
01 26Italy
01 13Active
02 13Inactive
01 8Complete
02 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9442
Submission : 1991-11-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-07
Pay. Date : 2015-01-27
DMF Number : 28997
Submission : 2015-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10727
Submission : 1994-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12509
Submission : 1997-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5998
Submission : 1985-05-28
Status : Inactive
Type : II