Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075874
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IFOSFAMIDE/MESNA KIT | IFOSFAMIDE; MESNA | 1GM/20ML;1GM/10ML (50MG/ML;100MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| IFOSFAMIDE/MESNA KIT | IFOSFAMIDE; MESNA | 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/26/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2015 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/26/2015 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/21/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/17/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/13/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |