Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076019
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
03/17/2004 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076019_s000_DeferoxamineTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/23/2023 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
10/23/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
12/14/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
DEFEROXAMINE MESYLATE
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 |
INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078718 | FRESENIUS KABI USA |
DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207384 | GLAND PHARMA LTD |
DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076019 | HOSPIRA |
DEFEROXAMINE MESYLATE | DEFEROXAMINE MESYLATE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 078086 | WEST-WARD PHARMS INT |