01 1Helsinn Advanced Synthesis
02 1MSN Laboratories
01 1India
02 1Switzerland
01 2Active
01 2Blank
01 1302MF10154
02 1Blank
01 2Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-05
Pay. Date : 2022-01-19
DMF Number : 35788
Submission : 2021-06-09
Status : Active
Type : II
NDC Package Code : 14501-0105
Start Marketing Date : 2015-02-28
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 : 31323
Submission : 2017-03-31
Status : Active
Type : II
Registration Number : 302MF10154
Registrant's Address : Via Industria, 24 6710 Biasca Switzerland
Initial Date of Registration : 2020-12-15
Latest Date of Registration : --
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