Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088372
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 200MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1986 | 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 |
|---|---|---|---|---|---|
| 12/03/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/07/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 10/11/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/31/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/08/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/18/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |