01 1Apotex Pharmachem
02 1CHEMO
03 1DEAFARMA
04 1MSN Laboratories
05 1Zhejiang Ausun Pharmaceutical
01 1Canada
02 1China
03 1India
04 1Italy
05 1Spain
01 3Active
02 2Blank
01 5Blank
01 5Blank
01 5Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-18
Pay. Date : 2017-09-20
DMF Number : 32077
Submission : 2017-11-07
Status : Active
Type : II
NDC Package Code : 76397-015
Start Marketing Date : 2018-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-30
Pay. Date : 2017-07-26
DMF Number : 31843
Submission : 2017-07-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-05
Pay. Date : 2017-09-22
DMF Number : 31948
Submission : 2017-08-30
Status : Active
Type : II
NDC Package Code : 69766-039
Start Marketing Date : 2017-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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