01 1Albert David
02 1Alfasigma
03 1Kothari Phytochemicals & Industries
04 1Labochem Ltd
05 1Medimpex
06 1Napp Technologies
07 2Pfizer Inc
08 2Blank
01 1MANUFACTURING & CONTROLS PROCEDURES USED IN PRODUCTION OF TOLBUTAMIDE
02 1ORINASE
03 1TOLBUTAMIDE
04 1TOLBUTAMIDE BULK
05 2TOLBUTAMIDE USP
06 1TOLBUTAMIDE USP (BULK)
07 1TOLBUTAMIDE USP XIX
08 1TOLBUTAMIDE USP, BULK FORM
09 1TOLBUTAMIDE, USP AND TOLBUTAMIDE, USP MILLED
01 1Greece
02 2India
03 1Italy
04 3U.S.A
05 1United Kingdom
06 2Blank
01 1Active
02 9Inactive
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5982
Submission : 1985-09-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 466
Submission : 1962-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25168
Submission : 2011-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4360
Submission : 1981-10-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3270
Submission : 1978-08-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3540
Submission : 1979-04-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 197
Submission : 1956-05-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4739
Submission : 1982-12-07
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5601
Submission : 1984-10-03
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 : 5320
Submission : 1984-04-06
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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