01 1Alivira Animal Health
02 1Anhui Sinotech Industrial
03 1BOC Sciences
04 1Changzhou Yabang- QH Pharmachem Co
05 1Elanco
06 1Eli Lilly
07 1Hangzhou Think Chemical Co.Ltd
08 1Hengdian Group
09 1Omshri Labs
10 1Zhejiang Guobang Pharmaceutical
01 5China
02 2India
03 3U.S.A
01 1Active
02 9Blank
01 3Valid
02 1Withdrawn by Holder
03 6Blank
01 10Blank
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8218
Submission : 1989-08-18
Status : Active
Type : II
Certificate Number : R1-CEP 2014-164 - Rev 02
Issue Date : 2023-04-14
Type : Chemical
Substance Number : 1718
Status : Valid
NDC Package Code : 59852-616
Start Marketing Date : 2021-04-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2019-083 - Rev 02
Issue Date : 2023-05-02
Type : Chemical
Substance Number : 1718
Status : Valid
NDC Package Code : 86055-0013
Start Marketing Date : 2018-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6287
Submission : 2018-12-31
Status : Active
Type : II
Certificate Number : R1-CEP 2003-107 - Rev 03
Issue Date : 2013-02-26
Type : Chemical
Substance Number : 1718
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2018-234 - Rev 03
Issue Date : 2023-04-27
Type : Chemical
Substance Number : 1718
Status : Valid
NDC Package Code : 51943-118
Start Marketing Date : 2023-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6288
Submission : 2019-01-02
Status : Active
Type : II
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