01 1Indena
02 1Sichuan Xieli Pharmaceutical
03 1Teva Pharmaceutical Industries
01 1China
02 1Israel
03 1Italy
01 1Active
02 1Inactive
03 1Blank
01 3Blank
01 3Blank
01 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-08-12
DMF Number : 29556
Submission : 2015-07-17
Status : Active
Type : II
NDC Package Code : 61200-037
Start Marketing Date : 2019-10-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28747
Submission : 2014-12-22
Status : Inactive
Type : II
NDC Package Code : 47848-047
Start Marketing Date : 2013-11-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
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