Deferoxamine Injectable Solution
- Brand(s)
- Desferal
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Novartis Pharmaceuticals Corporation (2012-01-01)
- Oldest Current Product
- 1968-04-02
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\DEFEROXAMINE
- FDAOB
- INJECTION\INJECTION\DEFEROXAMINE MESYLATE\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DEFEROXAMINE MESYLATE
- SPL Moiety
- INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DEFEROXAMINE
product(s) by strength(s)
deferoxamine mesylate 213 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780467 | Desferal | NDA | Novartis Pharmaceuticals Corporation | 1968-04-02 | DEFEROXAMINE MESYLATE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA016267 | a7174843-5965-49fc-b842-f7eff7b48bbc |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004092336 | ANDA | Hospira, Inc. | 2004-03-17 | DEFEROXAMINE MESYLATE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA076019 | 2e87cc7e-8856-4ec6-8c74-0356a352f522, f9ab6b1c-98d0-4373-0e9b-b10cb4a67543 |
| 2 | 004092337 | ANDA | Hospira, Inc. | 2004-03-17 | DEFEROXAMINE MESYLATE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA076019 | 2e87cc7e-8856-4ec6-8c74-0356a352f522, f9ab6b1c-98d0-4373-0e9b-b10cb4a67543 |
| 3 | 633230597 | ANDA | App Pharmaceuticals, Llc | 2009-12-15 | DEFEROXAMINE MESYLATE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA078718 | d91e16df-8daa-4cd2-86a2-273eaa2446e0 |
| 4 | 633230599 | ANDA | App Pharmaceuticals, Llc | 2009-12-15 | DEFEROXAMINE MESYLATE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA078718 | d91e16df-8daa-4cd2-86a2-273eaa2446e0 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076019 | DEFEROXAMINE MESYLATE | HOSPIRA INC | 2004-03-17 | ANDA076019_001, ANDA076019_002 | |
| 2 | ANDA076806 | DEFEROXAMINE MESYLATE | True | WATSON LABORATORIES INC | 2006-03-31 | ANDA076806_001, ANDA076806_002 |
| 3 | ANDA078086 | DEFEROXAMINE MESYLATE | EUROHEALTH INTERNATIONAL SARL | 2007-05-30 | ANDA078086_001, ANDA078086_002 | |
| 4 | ANDA078718 | DEFEROXAMINE MESYLATE | FRESENIUS KABI USA LLC | 2009-09-15 | ANDA078718_001, ANDA078718_002 | |
| 5 | NDA016267 | DESFERAL | NOVARTIS PHARMACEUTICALS CORP | NDA016267_001, NDA016267_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076019_001 | RX | DEFEROXAMINE MESYLATE (500MG/VIAL) | INJECTION | False | AP | 2004-03-17 | DEFEROXAMINE MESYLATE |
| 2 | ANDA076019_002 | RX | DEFEROXAMINE MESYLATE (2GM/VIAL) | INJECTION | False | AP | 2004-03-17 | DEFEROXAMINE MESYLATE |
| 3 | ANDA076806_001 | discontinued | DEFEROXAMINE MESYLATE (500MG/VIAL) | INJECTION | False | 2006-03-31 | DEFEROXAMINE MESYLATE | |
| 4 | ANDA076806_002 | discontinued | DEFEROXAMINE MESYLATE (2GM/VIAL) | INJECTION | False | 2006-03-31 | DEFEROXAMINE MESYLATE | |
| 5 | ANDA078086_001 | RX | DEFEROXAMINE MESYLATE (500MG/VIAL) | INJECTION | False | AP | 2007-05-30 | DEFEROXAMINE MESYLATE |
| 6 | ANDA078086_002 | RX | DEFEROXAMINE MESYLATE (2GM/VIAL) | INJECTION | False | AP | 2007-05-30 | DEFEROXAMINE MESYLATE |
| 7 | ANDA078718_001 | RX | DEFEROXAMINE MESYLATE (500MG/VIAL) | INJECTION | False | AP | 2009-09-15 | DEFEROXAMINE MESYLATE |
| 8 | ANDA078718_002 | RX | DEFEROXAMINE MESYLATE (2GM/VIAL) | INJECTION | False | AP | 2009-09-15 | DEFEROXAMINE MESYLATE |
| 9 | NDA016267_001 | RX | DEFEROXAMINE MESYLATE (500MG/VIAL) | INJECTION | True | AP | DESFERAL | |
| 10 | NDA016267_002 | RX | DEFEROXAMINE MESYLATE (2GM/VIAL) | INJECTION | True | AP | 2000-05-25 | DESFERAL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2e87cc7e-8856-4ec6-8c74-0356a352f522 (view SPL) | Deferoxamine Mesylate Rx only for Injection, USP | prescription | Human Prescription | Hospira, Inc. | 2015-01-09 | 11 | 004092336, 004092337 | |
| 2 | a7174843-5965-49fc-b842-f7eff7b48bbc (view SPL) | Desferal | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2012-01-01 | 7 | 000780467, 000780347 | |
| 3 | d91e16df-8daa-4cd2-86a2-273eaa2446e0 (view SPL) | Deferoxamine Mesylate for Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2012-04-13 | 4 | 633230597, 633230599 |
| 4 | f9ab6b1c-98d0-4373-0e9b-b10cb4a67543 (view SPL) | Deferoxamine Rx only Mesylate for Injection, USP | prescription | Human Prescription | Hospira, Inc. | 2015-01-09 | 11 | 004092336, 004092337 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII