Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201689
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IFOSFAMIDE | IFOSFAMIDE | 1GM/20ML (50MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| IFOSFAMIDE | IFOSFAMIDE | 3GM/60ML (50MG/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/26/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/21/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |