01 1Epoch Labs
02 1Hangzhou Longshine Bio-Tech
03 1Haoyuan Chemexpress Co.Ltd
04 1Hetero Drugs
05 1Lupin Ltd
06 1Mac-Chem Products (India) Pvt.Ltd
07 1Natco Pharma
08 1Viatris
09 1Zhejiang Lepu Pharmaceutical
01 3China
02 5India
03 1U.S.A
01 2Active
02 1Inactive
03 6Blank
01 9Blank
01 9Blank
01 9Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-16
Pay. Date : 2018-03-23
DMF Number : 32519
Submission : 2018-03-20
Status : Active
Type : II
NDC Package Code : 68578-0013
Start Marketing Date : 2018-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (7kg/1)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-30
Pay. Date : 2021-11-16
DMF Number : 36371
Submission : 2021-11-18
Status : Active
Type : II
NDC Package Code : 63850-8098
Start Marketing Date : 2023-11-25
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 : 32434
Submission : 2018-01-23
Status : Inactive
Type : II
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