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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 040024
Company: AM REGENT

Products on NDA 040024

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXFERRUM	FERRIC OXYHYDROXIDE	EQ 50MG IRON/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 040024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/1996	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2016	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/12/2009	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf
02/08/2002	SUPPL-12	Labeling		Label is not available on this site.
05/31/2001	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
02/18/2000	SUPPL-10	Labeling		Label is not available on this site.
07/20/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/20/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/25/1998	SUPPL-7	Labeling		Label is not available on this site.
09/25/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/25/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/25/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/29/1998	SUPPL-3	Labeling		Label is not available on this site.
01/29/1998	SUPPL-2	Labeling		Label is not available on this site.
09/19/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 040024

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2009	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf

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