01 1Akums Lifesciences
02 2Aurobindo Pharma Limited
03 1Covalent Laboratories Private Limited
04 2Daiichi Sankyo
05 1Nectar Lifesciences
06 1Orchid Pharma
07 1Qilu Antibiotics Pharmaceutical Co., Ltd.
08 1RANBAXY LABORATORIES LIMITED
09 2Sandoz B2B
01 4CEFPODOXIME PROXETIL
02 4CEFPODOXIME PROXETIL USP
03 1CEFPODOXIME PROXETIL USP (NON-STERILE BULK)
04 1CEFPODOXIME PROXETIL USP (PROCESS II)
05 1CS-807 CEFPODOXIME PROXETIL DRUG SUBSTANCE
06 1CS-807 TABLETS
01 1China
02 7India
03 2Japan
04 2Switzerland
01 8Active
02 4Inactive
01 4Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23572
Submission : 2010-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-09
Pay. Date : 2024-03-21
DMF Number : 39541
Submission : 2024-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 18941
Submission : 2005-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 29791
Submission : 2015-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 9886
Submission : 1987-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 6937
Submission : 1987-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-11
Pay. Date : 2014-06-18
DMF Number : 27071
Submission : 2014-06-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 18505
Submission : 2005-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-09
Pay. Date : 2020-01-21
DMF Number : 34502
Submission : 2020-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20076
Submission : 2006-12-26
Status : Active
Type : II
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