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 1TAPI Technology & API Services
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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