01 1ACS DOBFAR SPA
02 9Akums Lifesciences
03 2Aurobindo Pharma Limited
04 3Covalent Laboratories Private Limited
05 1Fako Ilaçlari A.S. TR 34390 Istanbul
06 1GSK
07 3Lupin Ltd
08 3Nectar Lifesciences
09 1Olon S.p.A
10 4Orchid Pharma
11 1Phlox Pharmaceuticals Ltd
12 3RANBAXY LABORATORIES LIMITED
13 1Sandoz B2B
14 1Sinopharm Weiqida Pharmaceutical Co Ltd
15 1TITAN PHARMACEUTICAL CO LTD GUANGDONG
16 1Unimark Remedies Limited
17 3Wockhardt
01 5CEFUROXIME ACID
02 1CEFUROXIME ACID (ACETONE ROUTE)
03 1CEFUROXIME ACID (API STARTING MATERIAL)
04 1CEFUROXIME ACID (PROCESS-III)
05 4CEFUROXIME AXETIL
06 2CEFUROXIME AXETIL (AMORPHOUS)
07 1CEFUROXIME AXETIL (AMORPHOUS) PROCESS II USP
08 1CEFUROXIME AXETIL (AMORPHOUS) USP
09 1CEFUROXIME AXETIL (CRYSTALLINE) (NON-STERILE BULK API)
10 1CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-III
11 1CEFUROXIME AXETIL (CRYSTALLINE) USP
12 1CEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP
13 1CEFUROXIME AXETIL AMORPHOUS
14 1CEFUROXIME AXETIL AMORPHOUS USP
15 1CEFUROXIME AXETIL BULK DRUG SUBSTANCE
16 1CEFUROXIME AXETIL CRYSTALLINE ( PROCESS-II )
17 1CEFUROXIME AXETIL DRUG SUBSTANCE
18 3CEFUROXIME AXETIL USP
19 3CEFUROXIME AXETIL USP (AMORPHOUS)
20 4CEFUROXIME AXETIL USP (CRYSTALLINE)
21 1CEFUROXIME AXETIL(CRYSTALLINE) USP
22 1CEFUROXIME AXETIL, AMORPHOUS
23 1CEFUROXIME AXETIL, CRYSTALLINE
24 1CEFUROXIME AXETIL, USP (AMORPHOUS)
01 2China
02 32India
03 2Italy
04 1Switzerland
05 1Turkey
06 1United Kingdom
01 26Active
02 13Inactive
01 1Complete
02 38Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10154
Submission : 1991-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18453
Submission : 2005-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17707
Submission : 2004-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16108
Submission : 2002-08-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14769
Submission : 2000-03-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17134
Submission : 2004-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17047
Submission : 2003-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17135
Submission : 2004-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20545
Submission : 2007-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16267
Submission : 2002-11-25
Status : Active
Type : II
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