Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203856
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription AB Yes No
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription AB Yes 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
09/16/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203856Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2019 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203856s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203856Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/26/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203856s003lbl.pdf
09/16/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf

CYCLOPHOSPHAMIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription No AB 207014 AMERIGEN PHARMS LTD
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription No AB 211608 CIPLA
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription No AB 209872 STI PHARMA LLC
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription Yes AB 203856 WEST-WARD PHARMS INT

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription No AB 207014 AMERIGEN PHARMS LTD
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription No AB 211608 CIPLA
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription No AB 209872 STI PHARMA LLC
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription Yes AB 203856 WEST-WARD PHARMS INT

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