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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021626
Company: HEYL CHEMISCH

Products on NDA 021626

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RADIOGARDASE (PRUSSIAN BLUE)	FERRIC HEXACYANOFERRATE(II)	500MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021626lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21626ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-626_Radiogardase.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2014	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021626s010lbl.pdf
09/12/2008	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/25/2008	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021626s007ltr.pdf
02/15/2008	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/20/2006	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/12/2005	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/30/2005	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/24/2004	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/11/2004	SUPPL-1	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21626scp001ltr.pdf

Labels for NDA 021626

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2014	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021626s010lbl.pdf
08/25/2008	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf
08/25/2008	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf
10/02/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021626lbl.pdf

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