01 1Global Calcium
02 1Harman Finochem
03 1Macco Organiques, Spol. s.r o
04 1Quality Chemicals
05 1Sudeep Pharma
06 1Valaji PharmaChem
07 1Vasa Pharmachem
08 1West Bengal Chemicals Industries
01 1Czech Republic
02 6India
03 1Spain
01 4Active
02 4Blank
01 1Valid
02 7Blank
01 8Blank
01 8Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-08-31
Pay. Date : 2023-06-27
DMF Number : 38075
Submission : 2023-03-15
Status : Active
Type : II
NDC Package Code : 64162-0098
Start Marketing Date : 2024-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36032
Submission : 2021-06-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-04
Pay. Date : 2024-03-25
DMF Number : 39271
Submission : 2023-12-20
Status : Active
Type : II
Certificate Number : CEP 2018-028 - Rev 01
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 1139
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-10
Pay. Date : 2022-05-05
DMF Number : 37019
Submission : 2022-05-06
Status : Active
Type : II
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