Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021626
Company: HEYL CHEMISCH
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 |