01 2Ajinomoto Company
02 1Aurobindo Pharma Limited
03 2Johnson & Johnson Innovative Medicine
04 1Jubilant Generics
05 1RANBAXY LABORATORIES LIMITED
06 1Sanochemia Pharmazeutika GmbH
07 2ScinoPharm Taiwan, Ltd
08 1Teva API
09 1Wuhan Shiji Pharmaceutical
10 1ZHEJIANG YIXIN PHARMACEUTICAL CO LTD
11 2Blank
01 1GALANTAMINE
02 1GALANTAMINE HBR
03 1GALANTAMINE HBR.
04 5GALANTAMINE HYDROBROMIDE
05 1GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE)
06 1GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC)
07 2GALANTAMINE HYDROBROMIDE USP
08 1GALANTAMINE HYDROBROMIDE USP (NON-STERILE DRUG SUBSTANCE)
09 1GALANTHAMINE HYDROBROMIDE
10 1Galanthamine Hydrobromide (Non-Sterile Bulk Form)
01 1Austria
02 2China
03 3India
04 1Israel
05 2Japan
06 2Taiwan
07 2U.S.A
08 2Blank
01 7Active
02 8Inactive
01 2Complete
02 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21934
Submission : 2008-09-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15384
Submission : 2001-05-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14425
Submission : 1999-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21989
Submission : 2008-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26643
Submission : 2012-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27564
Submission : 2013-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-24
Pay. Date : 2015-08-17
DMF Number : 17863
Submission : 2004-12-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-05
Pay. Date : 2012-11-08
DMF Number : 18112
Submission : 2005-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17967
Submission : 2005-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17972
Submission : 2005-01-05
Status : Active
Type : II
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