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Setid 21d9c619 7e94 49e2 Ac41 31e9ea96554a Applno 50718 Form Injectable Liposomal Injection Dosage 50mg 25ml 2mg Ml - Drug Product Composition: (7S,9S)-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione hydrochloride

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$ API Ref.Price (USD/KG) : 33,334Xls

USFDA APPLICATION NUMBER - 50718 / DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50MG/25ML (2MG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doxorubicin hydrochloride(UNII: 82F2G7BL4E)
(doxorubicin - UNII:80168379AG)
doxorubicin hydrochloride2mg in 1

Inactive Ingredients

Ingredient Name
BluePoint Laboratories
Janssen Products, LP
AMMONIUM SULFATE(SU46BAM238)
cholesterol(97C5T2UQ7J)
histidine(4QD397987E)
hydrochloric acid(QTT17582CB)
HYDROGENATED SOYBEAN LECITHIN(H1109Z9J4N)
sodium hydroxide(55X04QC32I)
SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE(3L6NN8ZZKU)
SUCROSE(C151H8M554)