Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076078
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IFOSFAMIDE | IFOSFAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
IFOSFAMIDE | IFOSFAMIDE | 3GM/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 |
---|---|---|---|---|---|---|---|
05/28/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076078.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/19/2024 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
08/19/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
IFOSFAMIDE
INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IFEX | IFOSFAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 019763 | BAXTER HLTHCARE |
IFOSFAMIDE | IFOSFAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076078 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 3GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IFEX | IFOSFAMIDE | 3GM/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 019763 | BAXTER HLTHCARE |
IFOSFAMIDE | IFOSFAMIDE | 3GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076078 | FRESENIUS KABI USA |