Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021626
Company: HEYL CHEMISCH
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
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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf
08/25/2008 SUPPL-7 Labeling-Container/Carton Labels 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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