Cyclophosphamide

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INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG, SOLUTION;INTRAVENOUS - 1GM/5ML (200MG/ML), SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML), SOLUTION;INTRAVENOUS - 500MG/2.5ML (200MG/ML)

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USFDA APPLICATION NUMBER - 212501 / DOSAGE - SOLUTION;INTRAVENOUS - 2GM/10ML (200MG/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CYCLOPHOSPHAMIDE ANHYDROUS(UNII: 6UXW23996M) (CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M)	CYCLOPHOSPHAMIDE ANHYDROUS	200mg in 1 \| 200mg in 1 \| 200mg in 1

Inactive Ingredients

Ingredient Name	BluePoint Laboratories
ALCOHOL(3K9958V90M)
MONOTHIOGLYCEROL(AAO1P0WSXJ)
NITROGEN(N762921K75)
POLYETHYLENE GLYCOL 400(B697894SGQ)
PROPYLENE GLYCOL(6DC9Q167V3)

Setid 0afd2cc7 09e6 481a Afea 9d2e3742da46 Applno 212501 Form Solution Intravenous Dosage 2gm 10ml 200mg Ml - Drug Product Composition: Cyclophosphamide