Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211757
Company: XGEN PHARMS
Company: XGEN PHARMS
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 |
---|---|---|---|---|---|---|---|
10/18/2022 | 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 | HENGRUI PHARMA |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216958 | HIKMA |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214529 | SAGENT PHARMS INC |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215089 | SUNNY |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211757 | XGEN PHARMS |
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 | HENGRUI PHARMA |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216958 | HIKMA |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214529 | SAGENT PHARMS INC |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215089 | SUNNY |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211757 | XGEN PHARMS |
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 | HENGRUI PHARMA |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216958 | HIKMA |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214529 | SAGENT PHARMS INC |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215089 | SUNNY |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211757 | XGEN PHARMS |