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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020207
Company: APOTEX

Products on NDA 020207

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALKERAN	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020207

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/1992	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		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-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020207s017ltr.pdf
06/09/2011	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf
06/14/2005	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020207s012ltr.pdf
04/29/2003	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20207slr007ltr.pdf
01/07/2002	SUPPL-5	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-4	Manufacturing (CMC)-Control		Label is not available on this site.
10/09/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/03/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/05/1994	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020207

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf
05/02/2011	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf
04/29/2003	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf

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