Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009386
Company: ASPEN GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYLERAN BUSULFAN 2MG TABLET;ORAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/24/2003 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pdf
04/16/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pdf
01/23/2003 SUPPL-19 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf
07/15/1991 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.pdf

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