01 1Kongo Chemical Co., Ltd.
02 1MSN Laboratories
03 1R L Fine Chem
04 1Symed Labs
05 1Tai Heng Industry Co., Ltd
06 1Taisho Pharmaceutical
07 1Tris Pharma Inc
08 2Blank
01 5CARBINOXAMINE MALEATE
02 1CARBINOXAMINE MALEATE API USP
03 1CARBINOXAMINE MALEATE USP
04 1CARBINOXAMINE MALEATE USP [ROUTE CODE - "CX"]
05 1KARBINAL ER (CARBINOXAMINE MALEATE) EXTENDED-RELEASE ORAL SUSPENSION EQ. TO 4 MG CARBINOXAMINE MALEATE PER 5 ML
01 1China
02 3India
03 2Japan
04 1U.S.A
05 2Blank
01 5Active
02 4Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-06
Pay. Date : 2014-03-04
DMF Number : 9844
Submission : 1992-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21301
Submission : 2008-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-18
Pay. Date : 2020-11-12
DMF Number : 34110
Submission : 2019-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21335
Submission : 2008-02-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21283
Submission : 2008-01-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2962
Submission : 1977-06-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33626
Submission : 2019-11-04
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8687
Submission : 1990-08-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3207
Submission : 1978-04-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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