Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040745
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Prescription AP No Yes
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Prescription AP No Yes
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/21/2008 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/040745Orig1s000ChemR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf
06/17/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf

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 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 JIANGSU 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 JIANGSU PHARMS

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