01 1Auronext Pharma Private Limited
02 1Hospira, Inc.
03 1Kopran
04 1Sandoz B2B
05 1Unimark Remedies Limited
01 1DORIPENEM (STERILE)
02 1DORIPENEM MONOHYDRATE (STERILE)
03 1DORIPENEM MONOHYDRATE, STERILE
04 2DORIPENEM STERILE
01 3India
02 1Switzerland
03 1U.S.A
01 1Active
02 4Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28212
Submission : 2014-05-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25239
Submission : 2011-11-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34913
Submission : 2020-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25372
Submission : 2011-10-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-10
Pay. Date : 2014-06-18
DMF Number : 28280
Submission : 2014-05-30
Status : Active
Type : II
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