01 1Chemi SpA
02 1Erregierre SpA
03 2Hikal
04 1Jubilant Generics
05 1Lupin Ltd
06 1Zhejiang Apeloa Jiayuan Pharmaceutical
07 1Zhejiang Supor Pharmaceuticals Co., LTD
01 4BUPROPION HYDROBROMIDE
02 1BUPROPION HYDROBROMIDE (FORM II)
03 1BUPROPION HYDROBROMIDE (FORM-I)
04 1BUPROPION HYDROBROMIDE API
05 1CHE001-05 (BUPROPIONE HYDROBROMIDE)
01 2China
02 4India
03 2Italy
01 7Active
02 1Inactive
01 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18922
Submission : 2005-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22419
Submission : 2009-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38384
Submission : 2023-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38231
Submission : 2023-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26720
Submission : 2013-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39224
Submission : 2023-12-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22809
Submission : 2009-05-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25254
Submission : 2011-08-23
Status : Active
Type : II
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