Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESFERAL | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DESFERAL | DEFEROXAMINE MESYLATE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/01/1968 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/09/2022 | SUPPL-62 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016267s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016267Orig1s062ltr.pdf | |
| 04/27/2016 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/2013 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2011 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016267s050ltr.pdf | |
| 09/07/2010 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016267s047ltr.pdf | |
| 01/28/2009 | SUPPL-45 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016267s045ltr.pdf | |
| 01/19/2007 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016267s044ltr.pdf | |
| 01/15/2002 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2002 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16267s39ltr.pdf |
| 07/05/2001 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/2002 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/2001 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/2001 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16267S34ltr.pdf |
| 05/25/2000 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/23/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/19/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/31/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1990 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/08/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/27/1985 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/02/1980 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1980 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/04/1979 | SUPPL-11 | Efficacy |
Label is not available on this site. |
||
| 04/06/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1977 | SUPPL-8 | Unspecified |
Label is not available on this site. |
||
| 01/20/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/09/2022 | SUPPL-62 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016267s062lbl.pdf | |
| 12/16/2011 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf | |
| 09/07/2010 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf | |
| 01/28/2009 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf | |
| 01/19/2007 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf |
DESFERAL
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078718 | FRESENIUS KABI USA |
| DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207384 | GLAND PHARMA LTD |
| DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076019 | HOSPIRA |
| DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078086 | WEST-WARD PHARMS INT |
| DESFERAL | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 016267 | NOVARTIS |