01 1Formosa Laboratories
02 1Raks Pharma
03 1Solara Active Pharma Sciences
04 1Viatris
05 1Vijayasri Organics Limited
06 1Zydus Lifesciences
01 4India
02 1Taiwan
03 1U.S.A
01 5Active
02 1Blank
01 6Blank
01 6Blank
01 6Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-20
Pay. Date : 2020-02-06
DMF Number : 33460
Submission : 2019-04-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-14
Pay. Date : 2022-02-18
DMF Number : 33423
Submission : 2018-12-29
Status : Active
Type : II
NDC Package Code : 72643-019
Start Marketing Date : 2020-02-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-29
Pay. Date : 2020-09-22
DMF Number : 17651
Submission : 2004-09-02
Status : Active
Type : II
NDC Package Code : 66499-0007
Start Marketing Date : 2006-04-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-24
Pay. Date : 2022-07-13
DMF Number : 33542
Submission : 2019-02-21
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-08
Pay. Date : 2023-02-15
DMF Number : 38026
Submission : 2023-02-24
Status : Active
Type : II
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