Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210046
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Prescription AP No No
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Prescription AP No No
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CYCLOPHOSPHAMIDE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 210046 AMNEAL
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 040745 BAXTER HLTHCARE
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204555 JIANGSU HENGRUI MED

INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 210046 AMNEAL
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 040745 BAXTER HLTHCARE
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 204555 JIANGSU HENGRUI MED

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 210046 AMNEAL
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 040745 BAXTER HLTHCARE
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 204555 JIANGSU HENGRUI MED

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