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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39418
Submission : 2024-03-06
Status : Active
Type : II
Certificate Number : R0-CEP 2022-054 - Rev 00
Issue Date : 2023-02-10
Type : Chemical
Substance Number : 39
Status : Valid
NDC Package Code : 12784-188
Start Marketing Date : 2012-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (97kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
Certificate Number : R1-CEP 2008-264 - Rev 00
Issue Date : 2014-11-17
Type : Chemical
Substance Number : 311
Status : Valid
Certificate Number : R1-CEP 2008-270 - Rev 00
Issue Date : 2014-11-18
Type : Chemical
Substance Number : 311
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39027
Submission : 2024-06-14
Status : Active
Type : II
NDC Package Code : 58103-132
Start Marketing Date : 2019-08-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (90kg/100kg)
Marketing Category : DRUG FOR FURTHER PRO...
Certificate Number : R1-CEP 2008-190 - Rev 00
Issue Date : 2014-10-07
Type : Chemical
Substance Number : 39
Status : Valid