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01 1Cetalkonium
02 1Dl-Histidine Monohydrochloride Monohydrate
03 1HEPES, Free Acid
04 1L-Arginine
05 1L-Arginine Hydrochloride API
06 1L-Histidine
07 1Polyethylene Glycol Excipient
08 1Sucrose API
09 1Sucrose Octasulfate
10 1Trehalose
11 1Trehalose API
12 2Tromethamine
13 1Blank
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01 14Active
01 14Blank
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01 14Blank
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01 14Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 37285
Submission : 2022-07-01
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 38369
Submission : 2023-12-27
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 38726
Submission : 2024-01-15
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 36553
Submission : 2021-12-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 35209
Submission : 2020-09-14
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 36552
Submission : 2022-02-24
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 34401
Submission : 2019-12-11
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 35566
Submission : 2021-01-31
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV
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DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV