01 1Biocon
02 1Brawn Laboratories Ltd
03 1Concord Biotech
04 1Fresenius Kabi AB Brunna
05 1Murli Krishna Pharma
06 1Sandoz B2B
07 1Shouyuan Chemical
08 1Sun Pharmaceutical Industries Limited
01 1China
02 5India
03 1Sweden
04 1Switzerland
01 4Active
02 1Inactive
03 3Blank
01 8Blank
01 8Blank
01 1WC-0100
02 1WC-0111
03 6Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24964
Submission : 2011-05-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-15
Pay. Date : 2014-12-08
DMF Number : 28841
Submission : 2015-01-22
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-02
Written Confirmation Number : WC-0100
Address of the Firm :
NDC Package Code : 65727-047
Start Marketing Date : 2014-09-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-10
Pay. Date : 2014-03-25
DMF Number : 24921
Submission : 2011-05-28
Status : Active
Type : II
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-6237
Start Marketing Date : 2011-02-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-01
Pay. Date : 2013-03-15
DMF Number : 26825
Submission : 2013-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26019
Submission : 2012-05-22
Status : Inactive
Type : II
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