23 Dec 2024
// PR NEWSWIRE
11 Dec 2024
// PRESS RELEASE
06 Dec 2024
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01 1ALECTINIB HYDROCHLORIDE
02 1APALUTAMIDE
03 1BALOXAVIR MARBOXIL
04 1CANAGLIFLOZIN
05 1DAPAGLIFLOZIN
06 1DARUNAVIR ETHANOLATE
07 1DEXRAZOXANE
08 1DN SULFONAMIDE
09 1DOUTEGRAVIR SODIUM DRUG SUBSTANCE (MON-STERILE)
10 1ISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCE
11 1MEFLOQUINE HYDROCHLORIDE
12 1NICOTINE (SYNTHETIC)
13 1NICOTINE USP
14 1PHLOROGLUCINOL DIHYDRATE
15 1RELUGOLIX
16 1SALMETEROL XINAFOATE API
17 1SODIUM (S)-4-OXO-4,6,7,8-TETRAHYDROPYRROLO[1,2-A]PYRIMIDINE-6-CARBOXYLATE
18 1TIOPRONIN NON-STERILE BULK DRUG
19 1TRIMETHYLPHLOROGLUCINOL DRUG SUBSTANCE (NON-STERILE)
20 1VIBEGRON
21 1VONOPRAZAN FUMARATE
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01 2PORTON FINE CHEMICALS LTD
02 19PORTON PHARMA SOLUTIONS LTD
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01 21China
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01 21Active
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01 1Complete
02 20Blank
GDUFA
DMF Review : N/A
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DMF Number : 40093
Submission : 2024-06-13
Status : Active
Type : II
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DMF Number : 39029
Submission : 2023-11-02
Status : Active
Type : II
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DMF Number : 40455
Submission : 2024-09-05
Status : Active
Type : II
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DMF Number : 39703
Submission : 2024-03-20
Status : Active
Type : II
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DMF Number : 39028
Submission : 2023-10-16
Status : Active
Type : II
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DMF Number : 33798
Submission : 2019-04-22
Status : Active
Type : II