Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040032
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG TABLET;ORAL Discontinued None No No
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG TABLET;ORAL Discontinued None 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
08/17/1999 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040032_cyclophosphamide_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2007 SUPPL-12 Labeling

Label is not available on this site.

01/10/2007 SUPPL-9 Labeling

Label is not available on this site.

07/17/2002 SUPPL-5 Labeling

Label is not available on this site.

07/17/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/17/2002 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/16/2000 SUPPL-1 Labeling

Label is not available on this site.

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