01 1Hybio Pharmaceutical
02 1MSN Laboratories
03 1Viatris
01 2ABALOPARATIDE
02 1ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCE
01 1China
02 1India
03 1U.S.A
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-08
DMF Number : 39223
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-16
Pay. Date : 2022-05-06
DMF Number : 34697
Submission : 2020-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36475
Submission : 2021-12-03
Status : Active
Type : II
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