01 1Alkaloida Chemical Company Zrt
02 1DMFs Not Supported
03 1F. Hoffmann-La Roche
04 1Harman Finochem
05 1Nantong Jinghua Pharmaceutical
06 1Shandong Xinhua Pharmaceutical
07 2Siegfried AG
08 2Blank
01 1CALCIUM PHENOBARBITAL
02 1HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS
03 1PENTOBARBITOL SODIUM USP
04 2PHENOBARBITAL
05 1PHENOBARBITAL SODIUM USP
06 1PHENOBARBITAL TIMED RELEASE PELLETS
07 2PHENOBARBITAL USP
08 1SYNTHESIS OF PHENOBARBITAL, BULK FORM
01 2China
02 1Hungary
03 1India
04 3Switzerland
05 3Blank
01 6Active
02 4Inactive
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4642
Submission : 1982-09-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 778
Submission : 1964-01-24
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3756
Submission : 1980-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17823
Submission : 2004-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31321
Submission : 2017-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27827
Submission : 2013-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1169
Submission : 1968-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1049
Submission : 1967-03-21
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4714
Submission : 1982-11-10
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 : 1003
Submission : 1966-10-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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