GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42462
Submission : 2025-12-25
Status : Active
Type : IV

Registrant Name : J2H Biotech Co., Ltd.
Registration Date : 2023-08-07
Registration Number : 20230807-210-J-1532
Manufacturer Name : Shantou Jiahe Biologic Technology Co., Ltd
Manufacturer Address : 349 B-dong, Sandan-ro, Danwon-gu, Ansan-si, Gyeonggi-do, D-dongilbu @ No. 4 Lane 1, Xigang Road, Shantou, Guangdong, China

Registrant Name : Bigsol Bio Co., Ltd.
Registration Date : 2025-08-25
Registration Number : 20250825-210-J-1993
Manufacturer Name : Shanghai Ajinomoto Amino Acid Co., Ltd.
Manufacturer Address : No. 718 East Rongle Road, Songjiang District, Shanghai 201613, China

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FINISHED DOSAGE FORMULATIONS
Drug : AVONEX
Dosage Form : VIAL
Application Number : 103628
Country : US
Patented : No

Drug : KINEVAC
Dosage Form : POWDER; INTRAVENOUS
Application Number : 17697
Country : US
Patented : No

Drug : BENLYSTA
Dosage Form : INJECTABLE; INJECTION
Application Number : 761043
Country : US
Patented : No

Drug : SINCALIDE
Dosage Form : POWDER; INTRAVENOUS
Application Number : 210850
Country : US
Patented : Yes

Drug : BENLYSTA
Dosage Form : INJECTABLE; INJECTION
Application Number : 125370
Country : US
Patented : No

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EXCIPIENTS BY APPLICATIONS