01 1Alchymars ICM SM
02 1Curia
03 1Shouyuan Chemical
04 2Viatris
05 1Vintage Pharmaceuticals-Charlotte
01 1China
02 1India
03 4U.S.A
01 4Active
02 2Blank
01 6Blank
01 6Blank
01 6Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12419
Submission : 1997-03-17
Status : Active
Type : II
NDC Package Code : 65392-2801
Start Marketing Date : 1998-06-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24722
Submission : 2011-03-08
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2013-12-19
DMF Number : 24615
Submission : 2011-05-03
Status : Active
Type : II
NDC Package Code : 65015-889
Start Marketing Date : 2018-11-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32292
Submission : 2017-12-19
Status : Active
Type : II
NDC Package Code : 65015-889
Start Marketing Date : 2018-11-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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