01 1Chromo Laboratories
02 1Hetero Drugs
03 1Viatris
04 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 1China
02 2India
03 1U.S.A
01 2Active
02 2Blank
01 4Blank
01 4Blank
01 4Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-09
Pay. Date : 2022-06-17
DMF Number : 37216
Submission : 2022-06-23
Status : Active
Type : II
NDC Package Code : 68554-0132
Start Marketing Date : 2018-08-30
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 : 38795
Submission : 2023-10-06
Status : Active
Type : II
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