01 1ACS DOBFAR SPA
02 1Aurobindo Pharma Limited
03 1CordenPharma
04 1Fresenius Kabi AB Brunna
05 1Qilu Pharmaceutical
06 1Tecoland Corporation
01 1China
02 1Germany
03 1India
04 1Italy
05 1Sweden
06 1U.S.A
01 2Inactive
02 4Blank
01 6Blank
01 6Blank
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18081
Submission : 2005-02-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26969
Submission : 2013-03-06
Status : Inactive
Type : II
NDC Package Code : 52946-0815
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5700
Submission : 2000-12-15
Status : Active
Type : II
NDC Package Code : 59651-930
Start Marketing Date : 2024-01-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5868
Submission : 2021-05-21
Status : Active
Type : II
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