Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014691
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALKERAN MELPHALAN 2MG TABLET;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
01/17/1964 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
05/02/2011 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s030ltr.pdf
06/09/2011 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf
06/09/2005 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/014691s028ltr.pdf
05/14/2003 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/14691slr024ltr.pdf
01/07/2002 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf
10/09/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/24/2001 SUPPL-20 Manufacturing (CMC)-Control Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14691s20ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/NDA/2001/14-691S20_Alkeran.cfm
07/14/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1994 SUPPL-16 Labeling

Label is not available on this site.

09/26/1989 SUPPL-15 Labeling

Label is not available on this site.

03/26/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1987 SUPPL-13 Labeling

Label is not available on this site.

09/22/1986 SUPPL-12 Labeling

Label is not available on this site.

09/19/1984 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1984 SUPPL-10 Labeling

Label is not available on this site.

03/24/1982 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/16/1980 SUPPL-7 Labeling

Label is not available on this site.

06/16/1980 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/09/2011 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf
05/02/2011 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf
05/14/2003 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf

ALKERAN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALKERAN MELPHALAN 2MG TABLET;ORAL Prescription Yes AB 014691 APOTEX INC
MELPHALAN MELPHALAN 2MG TABLET;ORAL Prescription No AB 207809 ALVOGEN MALTA

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