01 1F.I.S. Fabbrica Italiana Sintetici
02 2GLAND PHARMA LIMITED
03 1H. Lundbeck AS
04 1Solara Active Pharma Sciences
01 1Denmark
02 3India
03 1Italy
01 4Active
02 1Blank
01 5Blank
01 1227MF10093
02 4Blank
01 1WC-0427A3-4
02 4Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22751
Submission : 2009-04-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-31
Pay. Date : 2015-09-30
DMF Number : 29441
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25401
Submission : 2011-10-31
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-22
Pay. Date : 2014-11-28
DMF Number : 27282
Submission : 2013-10-24
Status : Active
Type : II
Registration Number : 227MF10093
Registrant's Address : Via Quarta Strada, 2 Padova, Italy
Initial Date of Registration : 2015-03-12
Latest Date of Registration : --
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