Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022041
Company: BTG INTL
Company: BTG INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYANOKIT | HYDROXOCOBALAMIN | 5GM/VIAL (5GM/KIT) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| CYANOKIT | HYDROXOCOBALAMIN | 2.5GM/VIAL (5GM/KIT) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/31/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022041s019, 020lbl.pdf | |
| 12/31/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022041s019, 020lbl.pdf | |
| 04/08/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf | |
| 04/08/2011 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf | |
| 10/13/2010 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s004lbl.pdf | |
| 02/19/2010 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s007lbl.pdf | |
| 06/04/2009 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022041s005lbl.pdf | |
| 12/15/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf |