01 1ACS DOBFAR SPA
02 1Aurobindo Pharma Limited
03 1Bristol Myers Squibb
04 3Eli Lilly
05 1Kyongbo Pharmaceutical Co., Ltd
06 2Lupin Ltd
07 1RANBAXY LABORATORIES LIMITED
08 1TAPI Technology & API Services
09 1Yuhan Corporation
10 2Blank
01 17-ACCA
02 5CEFACLOR
03 1CEFACLOR BULK
04 1CEFACLOR BULK NON STERILE AADA CONVERSION
05 1CEFACLOR MONOHYDRATE
06 1CEFACLOR MONOHYDRATE USP, NON-STERILE BULK
07 1CEFACLOR NON-STERILE API
08 2CEFACLOR USP
09 1CEFACLOR USP AS MAUFACTURED IN MANDIDEEP, INDIA
01 4India
02 1Israel
03 1Italy
04 2South Korea
05 4U.S.A
06 2Blank
01 2Active
02 12Inactive
01 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13780
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13218
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13622
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13598
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13647
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12086
Submission : 1996-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13217
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13790
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14211
Submission : 1997-04-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13226
Submission : 1998-04-30
Status : Inactive
Type : II
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