01 2ACS DOBFAR SPA
02 1Ajanta Pharma Limited
03 1Aurobindo Pharma Limited
04 1Bristol Myers Squibb
05 1CordenPharma
06 1Hikma Pharmaceuticals
07 1Lupin Ltd
08 1Orchid Pharma
09 2RANBAXY LABORATORIES LIMITED
10 1TAPI Technology & API Services
11 3Blank
01 8CEFADROXIL
02 2CEFADROXIL MONOHYDRATE
03 1CEFADROXIL MONOHYDRATE BULK
04 3CEFADROXIL USP
05 1CEFADROXIL USP, HEMIHYDRATE, (NON-STERILE BULK)
01 1Germany
02 6India
03 1Israel
04 2Italy
05 1U.S.A
06 1United Kingdom
07 3Blank
01 5Active
02 10Inactive
01 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13225
Submission : 1998-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13614
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18331
Submission : 2005-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13566
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19290
Submission : 2006-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17106
Submission : 2004-01-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12894
Submission : 1998-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17509
Submission : 2004-07-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8391
Submission : 1990-01-25
Status : Inactive
Type : II
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