Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087442
Company: BEDFORD
Company: BEDFORD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOSAR | CYCLOPHOSPHAMIDE | 100MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NEOSAR | CYCLOPHOSPHAMIDE | 200MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NEOSAR | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NEOSAR | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NEOSAR | CYCLOPHOSPHAMIDE | 2GM/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 |
|---|---|---|---|---|---|---|---|
| 02/16/1982 | 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 |
|---|---|---|---|---|---|
| 03/25/2002 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 03/03/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 08/19/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/06/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/30/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 03/30/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/30/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/18/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/12/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |