01 1Cadila Pharmaceuticals
02 1Divis Laboratories
03 1EASTMAN KODAK
04 1ERREDUE S.P.A. IT 24040 Isso
05 1Harman Finochem
06 1KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD
07 1Katwijk Chemie
08 1Orchid Pharma
09 1Pfizer Inc
10 2Recordati
11 1Unichem Laboratories Limited
01 15-PHENYLHYDANTOIN
02 1AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES
03 1PHENYTOIN MICRO
04 4PHENYTOIN SODIUM
05 2PHENYTOIN SODIUM USP
06 2PHENYTOIN USP & PHENYTOIN SODIUM USP
07 1PHENYTOIN/PHENYTOIN SODIUM
01 1China
02 5India
03 3Italy
04 1Netherlands
05 2U.S.A
01 8Active
02 4Inactive
01 4Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7304
Submission : 1988-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16301
Submission : 2002-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 17862
Submission : 2004-12-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-15
DMF Number : 5384
Submission : 1984-06-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20433
Submission : 2007-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20453
Submission : 2007-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7229
Submission : 1987-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4531
Submission : 1982-04-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-18
Pay. Date : 2024-10-15
DMF Number : 4538
Submission : 1982-04-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-31
Pay. Date : 2018-03-27
DMF Number : 32676
Submission : 2018-03-29
Status : Active
Type : II
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