01 1BioSpectra
02 1Eagle Chemical
03 1Finar
04 1Hefei TianRui Pharmaceutical Chemical
05 1Jost Chemical
06 1Minsheng Group Shaoxing Pharmaceutical
01 2China
02 2India
03 2U.S.A
01 6Active
01 6Blank
GDUFA
DMF Review : N/A
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DMF Number : 33447
Submission : 2020-03-04
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 43377
Submission : 2025-12-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 37296
Submission : 2022-07-07
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 40617
Submission : 2024-09-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 36287
Submission : 2022-05-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43746
Submission : 2026-03-03
Status : Active
Type : IV
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