Drugs@FDA: FDA-Approved Drugs

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/26/1954 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/24/2003 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr023ltr.pdf
04/16/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr021ltr.pdf
09/20/2002 SUPPL-20 Labeling

Label is not available on this site.

01/23/2003 SUPPL-19 Manufacturing (CMC) Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386scm019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/9-386s019_Myleran.cfm
09/06/2000 SUPPL-18 Labeling

Label is not available on this site.

03/15/2000 SUPPL-17 Labeling

Label is not available on this site.

12/23/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/29/1994 SUPPL-15 Labeling

Label is not available on this site.

07/15/1991 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.pdf
09/17/1990 SUPPL-12 Labeling

Label is not available on this site.

03/20/1990 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1987 SUPPL-10 Labeling

Label is not available on this site.

04/09/1987 SUPPL-9 Labeling

Label is not available on this site.

05/19/1986 SUPPL-8 Labeling

Label is not available on this site.

05/11/1981 SUPPL-7 Labeling

Label is not available on this site.

11/08/1979 SUPPL-6 Labeling

Label is not available on this site.

02/10/1977 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/1975 SUPPL-4 Unspecified

Label is not available on this site.

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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